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Bioanalytics
W1030-04-028 - A Platform Technology For The Rapid Generation Of Robust Anti-Idiotypic Binders For Clinical PK Assays

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W1130-04-028 - A Diagnostic Tool for Red Blood Cell Disorders - Chipcytometry as a New RBC Analysis Platform

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M1130-04-025 - A Fit for Purpose Validation of a Single Plate Assay for the Quantification of Total and Bound Cytokine

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T1030-03-021 - A Gyros Multiplex Bioanalytical Strategy for Monitoring a Fusion Fc-Peptide Biotransformation In Vivo

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M0930-03-021 - A Hybrid IC-LC-MS/MS Approach to the Quantification of CD154 from Plasma

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T0930-03-017 - A Hybrid LBA/LC-MS Assay for Multiplex Quantitation of Insulin Analogs in Plasma

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T1330-04-025 - A LC-MS/MS Method for Quantitation of Temozolomide in Mice Brain following Intra Cerebral Brain Micro-dialysis

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T1030-04-029 - A Middle-Down Analytical Strategy for Determination of Mature Growth Differentiation Factor-15 (GDF-15) in Human Serum Using Immunoaffinity Enrichment – Liquid Chromatography/Tandem Mass Spectrometry

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T0930-03-021 - A Multiplex Bead-Based Immunoassay (Luminex) for the Analysis of Inflammatory Cytokines in Mouse Serum

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M0930-04-027 - A New Immunoaffinity Extraction Method for Rapid Diagnosis of Paralytic Shellfish Poisoning in Humans

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M1230-03-020 - A Novel and Sensitive UPLC-MS/MS Method for the Determination of Mequitazine in Rat Plasma and Urine

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M1130-03-020 - A Novel Immunoassay for Assessment of Specific Anti-Drug IgE Antibodies

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M1330-03-023 - A Novel Lispro ELISA for Specific Determination of the Rapid-Acting Insulin Analog, Insulin Lispro, in Human Samples

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M1130-03-017 - A Novel Robust Approach to Detect Treatment-Boosted Anti-Drug Antibodies (ADA) in a Study Population with Pre-Existing ADA

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T1430-04-028 - A pH-sensitive Liposome Approach to Target the Survivin Protein: Overcoming Cancer Chemoresistance in Retinoblastoma

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T1330-03-018 - A Rapid and Selective Method for 5-Azacytidine in Rat Plasma, Lung, Brain, and Liver Using LC-MS/MS

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M1430-03-022 - A Sensitive Enantioselective LC-MS/MS Method for the Determination of Dasotraline in Human Plasma and Its Application to Clinical Development

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W1130-03-020 - A Sensitive Liquid Chromatography-Mass Spectrometry Method for Detection of Usnic Acid in Rat Plasma and Its Application to Pharmacokinetic Study of Transdermal Administration

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M1530-03-017 - A Sensitive Microflow LC/MS/MS Method for the Analysis of Fluticasone Propionate in Human Plasma

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M1330-04-028 - A Simplified and Automated LC-MS/MS Method to Determine of 25-OH-Vitamin D2/D3 in Human Serum Using Strata RP Online Extraction Column

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W1130-03-021 - A Targeting Theranostics Nanomedicine for Real-Time Monitoring Drug-Release

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T1330-03-017 - A UPLC-MS/MS Method for the Simultaneous Determination of Diethyl Phthalate and Its Metabolite, Monoethyl Phthalate, in Rat Plasma, Urine, and Various Tissues Collected from a Toxicokinetic Study

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M1330-03-017 - Absolute Quantitation of Biotherapeutic Drug Product and Endogenous Protein in Human Serum Using a Hybrid Immunoassay-LC/MS Approach

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T0930-04-029 - Absolute Quantitation of Five Antibody Drug Products in Dosed Monkey Serum, CSF and Brain Lysate for Lead Candidate Identification Using LC-MRM/MS

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T0930-03-018 - ADC PK Profiling Strategies on LC-MS Platforms: Top-Down, Bottom-Up, and Multiplexing

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M1530-03-020 - Advances in Approval of Topical Dermatological Generic Drug Products Pertinence of New FDA Drafted Guidance on Acyclovir Cream-IVRT/IVPT

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W0930-03-020 - Aegyris™ – The Simple and Efficient Software Solution for the Validation of Immunogenicity Assays to Support Vaccine Clinical Trials

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W1130-04-025 - An LC-MRM/MS-Based PD Assay for Monitoring Site Occupancy of an Oncogene Protein in Tumor Xenograft Tissue from Mice Dosed with Alkylating Agent

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T1030-04-028 - Analysis of Anamorelin Stereoisomers in Human Plasma Using Coupled Achiral / Chiral HPLC with Tandem Mass Spectroscopy Detection

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M1330-04-027 - Analysis of Arachidonic Acid as a Biomarker in Human Plasma Using LC-MS/MS for Clinical Studies

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W1230-04-025 - Analytical Challenges in Quantitation of Nanoparticle Encapsulated Material

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T1030-04-026 - Analytical Comparability Strategies for Rituximab and Its Biosimilar

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W1230-03-021 - Analytical Method for the Quantification of Magnesium Ascorbyl Phosphate (MAP) in Isotonic Normal Saline with Ion-Pair Chromatography

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W0930-03-018 - Anti-Drug Antibody Data Management Using E-Workbook

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T0930-04-028 - Application of Multivariate Analysis of FTIR and CD Spectroscopy Data to Differentiates Structural Perturbations in Proteins

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W0930-04-025 - Application of Taylor Dispersion to the Particle Size Characterization of mRNA and mRNA-loaded Lipid Nanoparticles

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T1530-04-025 - Application of the Multi-Attribute Method (MAM) in Lot-to-Lot Comparison of Rituximab Drug Product

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M1430-04-026 - Assessing the Predictive Response of a Simple and Sensitive Blood-Based Biomarker between Estrogen-Negative Solid Tumors

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M1130-04-027 - Association of Salivary Biomarkers with Skeletal Maturation in Orthodontic Patients

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M1130-04-029 - Automated Analysis of Melanoma Gene Expression Patterns by Sequential Interrogation of Variable RNA Average Count-space

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W1230-03-017 - Automated High-Throughput Sample Preparation of Insulin-Like Growth Factor 1 for Targeted LC-MS/MS Quantification

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T1430-04-027 - Bacteria and Human Cells-Mediated Synthesis of Biogenic Metallic Nanoparticles. A Nanometric Trojan Horse Approach

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M1330-04-029 - Bioanalysis of Plasma Amino Acids as Potential Biomarkers of NSAIDs-Induced Gastric Injury by Liquid Chromatography-Tandem Mass Spectrometry

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T1030-04-027 - Cannabis for Medical Purposes: Simultaneous Quantification of 11 Cannabinoids in Cannabis by UPLC-UV

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M1430-03-020 - Case Study to Address Matrix Interference in a PK Assay: Serum versus Plasma

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T1530-03-020 - Challenges of Cross-Lab Validation for Sphingolipids Biomarker Assays with Multiple Isomers in Human Dried Blood Spots

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W1030-03-017 - Characterization of Exosomes Derived from Cancer Resistant Cells as a Drug Delivery Carrier

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M1530-04-028 - Characterization of Two Kinase-Modulating Compounds in Tumor Infiltrating Lymphocytes (TILs) Using Flow Cytometry and Meso Scale Discovery

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M1030-03-019 - Co-delivery of Doxorubicin and Erlotinib by Dual Functionalized Liposomes on Glioblastoma Tumor Regression Using an In Vitro Brain Tumor Model

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T1430-03-020 - Comparability, Similarity, Linearity and High Order Structure Analysis of an IgG1 Sample by Microfluidic Modulation Spectroscopy

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M1130-03-018 - Controlling Effects of IgG4 Hybrid Antibody Formation in Bridging Immunogenicity Assays

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M1030-04-029 - Detection and Identification of New Protein Features Using Multi-attribute Monitoring (MAM) as Part of Mass Spectrometry-Based Quality Control (QC)

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M0930-04-026 - Determination of Triazolam and Its Two Major Metabolites in Mouse In Vivo Using SFC Coupled with Mass Spectrometry

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T1430-04-026 - Developing and Qualifying the Anti-drug Antibody (ADA) Assay for a Bispecific Nanobody by Electrochemiluminescence (ECL) Immunoassay

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W1030-03-018 - Development and Assessment of Novel Fluorescent Hyaluronic Acid Nano-Particulate System for Biomedical Applications in Bio-Imaging, Drug Delivery, and Bio-Sensing

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W1030-04-029 - Development and Characterization of Mouse Th17-Related and Cytokine Multiplex V-PLEX® Assays

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T1530-04-029 - Development and Implementation of a Rapid Generic Ig Dip and Read Ligand Binding Assay Format on the Octet RED 384™ for the Quantitation of Human IgG in Mouse Plasma

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M0930-04-030 - Development and Optimization of a Liquid Chromatography Tandem Mass Spectrometry Method for Quantification of Bevacizumab and Ranibizumab in Human Plasma after Intravitreal Administration

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M1030-03-022 - Development and Proof-of-Concept of a New Flow-through System for High Resolution NMR to Evaluate Biologics-Producing Cell Lines and Their Growth Environments

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T1530-03-019 - Development and Validation of a Human Total Soluble OX40 Biomarker Assay for use on Clinical Studies

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W1130-03-022 - Development and Validation of a LC-MS/MS Method for the Determination of Perampanel in Human Plasma

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W1130-03-019 - Development and Validation of a UPLC-MS/MS Method and Comparison with an HPLC-UV Method for Simultaneous Determination of cis-, trans-cefprozil Isomer in Human Plasma

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T1230-03-019 - Development and Validation of an ELISA Method for the Determination of Anti-Polyethylene Glycol (PEG) Antibodies in Human Serum

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M1430-03-019 - Development and Validation of an Immunoassay for Total Therapeutic Antibody (RO7112689; SKY59) Quantification in the Presence of C5 and that for Total C5 Quantification in Cynomolgus Monkey Plasma

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M1330-03-019 - Development and Validation of LC-MS/MS Assay for 5-Amino-1-Methyl Quinolinium in Rat Plasma

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M1230-03-018 - Development and Validation of LC-MS/MS Assay for Simultaneous Analysis of Simvastatin, Atorvastatin, Rosuvastatin and Their Active Metabolites in Plasma of Obese Subjects Underwent Bariatric Surgery

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M0930-03-022 - Development and Validation of Robust Analytical Method to Quantify rhSOD3 from Mouse Plasma via HPLC-MS/MS

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T1330-04-027 - Development of a Simple and Sensitive LC-MS/MS Method for the Determination of Tramadol and Its Metabolites in Human Plasma

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T1130-04-025 - Development of a Ultra-Sensitive Digital Immunoassay for Human Soluble HLA-E Biomarker

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M1130-03-022 - Development of an Anti-Drug Antibody Assay with High Drug Tolerance for Bevacizumab (Avastin®) and Its Biosimilars

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T1030-03-019 - Development of an HPLC Method for Simultaneous Detection of Pterostilbene and Its Metabolites

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M0930-03-018 - Development of an Immunoaffinity-LC-MS/MS Bioanalytical Method for the Highly Sensitive Quantification of Active Infliximab and Adalimumab

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T1330-03-021 - Development of an LC-MS/MS Method for Determining Methylsulfonylmethane (MSM) Pharmacokinetics in Humans

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M1430-03-017 - Development of an LC-MS/MS Method for Quantification of Cytarabine in Rat Plasma

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W1230-03-018 - Development of an Ultra-Sensitive Biomarker Assay for Megakaryocyte Potentiating Factor

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M1030-03-017 - Development of Antibodies and PK and ADA Assays for a Cysteine Knot Fusion Protein

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M1430-03-024 - Development of High Sensitivity and Specificity LC-MS/MS Method to Evaluate Peptide Permeability across Cell Monolayer

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T0930-03-022 - Development of NISTmAb-derived homogeneous antibody-drug conjugate (ADC) standards

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M0930-04-029 - Development of Novel Mass Spectrometry Methods for the Determination of Drug to Antibody Ratio of Interchain Cysteine Linked Antibody Drug Conjugates(ADC)

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M1330-03-024 - Diagnosing and Solving Phospholipid-Based Matrix Effects in LC-MS Bioanalysis

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T1030-03-017 - Discovery of Antibacterial Properties of Pyrimidine Derivatives by High Throughput Screening of Pre-metabolized Chemical Library

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T1130-03-018 - Dual Functionalized Liposomes for Co-delivery of Anti-cancer Chemotherapeutics to Brain Tumor

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T1130-04-030 - Echinacea purpurea as an Herbal Adjuvant for Vaccine-Based Cancer Therapy

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T1230-03-021 - Effector and Regulatory T Cell Epitope Content, and not Humanization nor Biophysical Properties, is Predictive of Antibody Immunogenicity

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M1430-03-023 - Efficient and Economical Preclinical Pharmacokinetic Analyses for Human Therapeutic Antibodies and Constructs, Using a Validated Human Immunoglobulin Immunoassay in Plasma of Mice, Rats, and Monkeys

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T1230-04-025 - EGFR Transactivation by Endothelin Receptor Involves a Src Activated Pro-HBEGF Cleavage in Asthmatic Airway Smooth Muscle (ASM) Cells

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T1130-04-031 - Enhancing the Antitumor Activity of Adenovirus Vaccines by Combining with Intratumoral Delivery of CpG-loaded Nanoparticles.

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M1030-04-028 - Evaluating Platelet Reactivity via Laser Defraction Particle Analysis

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M1430-03-018 - Evaluation of an ELISA Method Using Novel Amplification Reagent and Its Comparison with Traditional Colorimetric ELISA Assay for the Measurement of Aflibercept in Biological Matrices

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W0930-04-027 - Evaluation of Generic PK Assay: Comparison between ELISA and Ella Platform

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T1430-04-025 - Evaluation of the Subcellular Uptake and Distribution of Gemini Surfactant Gene Delivery Nanoparticles Using Mass Spectrometry

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W1130-04-026 - Fit-for-Purpose GLP Validation of an Intra-Cellular Cytokine Staining Assay

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T1230-04-029 - Fit-for-Purpose Validation for the Measurement of 29 Cytokines in Human Plasma by MesoScale

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W0930-04-029 - Functional Bioassay Miniaturization is Enhanced by Using Acoustic Liquid Handling for Antibody Transfer

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M1430-04-027 - Galactose Single Point Test as a Safe, Simple, Highly-Sensitive Quantitative Liver Function Assessment in Patients with Non-alcoholic Fatty Liver Disease

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T1230-04-028 - Glycogen Synthase as Biomarker for Neurodegenerative Lafora Disease

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W1230-04-026 - Green Synthesis of a Synergetic Structure of Tellurium Nanowires and Metallic Nanoparticles for Biomedical Applications

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T1230-03-022 - HLA DR-binding Assays as a Tool for Immunogenicity Screening: Developing the Best Practices for Determining Immunogenicity

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T1530-04-027 - How Does Hydroxypropyl-ß-cyclodextrins Inhibit Human Growth Hormone Aggregation?

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W1230-03-019 - HSP47 Immunoassay Validation and Application to Analysis of Normal and Disease Samples

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T1130-04-026 - Image Cytometry: A New Method for Deep Phenotyping of Rare Cells in the Blood of Oncology Patients

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W0930-03-017 - Impact of Critical Reagents Characterization and Handling on Anti-Drug Antibodies (ADA) Assay Method Development: A Case Study for a Humanized Monoclonal IgG ADA Assay

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W1030-03-022 - Improved Acceptance Criteria for Laboratory Developed Flow Cytometry Tests

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T1530-03-017 - Improved Sample Processing to Optimize Stability for Total Glutathione Determination in Human Plasma Using a Fit-for-Purpose Approach

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T1230-03-020 - Improving Drug Tolerance by Going Back to the Basics

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T1030-03-020 - In Vivo Assessment of Multiple Quality Attributes of Protein Therapeutics and Their Biological Relevance by High Resolution Liquid Chromatography Mass Spectrometry and Multiplexed Proteomics Approach

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T0930-04-027 - Influence of Chitosan Coating on the Oral Bioavailability of Gold Nanoparticles in Rats

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T0930-03-020 - Inhibition on Esterase Mediated Hydrolysis of Simvastatin in Rat Blood and the Impact on iIs Pharmacokinetics in Rats

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T1330-03-019 - LC/MS/MS Method for the Quantification of Metronidazole in Skin Dialysate

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W1130-03-017 - LC-MS Method Development of Midazolam and Ketamine: Application to a Pharmacokinetic Study in Patients on Extracorporeal Membrane Oxygenation Therapy

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M1430-04-025 - LC-MS/MS Method for Quantitative Tissue Distribution Analysis (QTDA) of Targeted Metabolomics

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M1130-04-026 - LC-MS/MS Method for the Quantification of 3,4-Dihydroxyphenylglycol (DHPG), a Biomarker for MAO-A Inhibition

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M1330-04-025 - LC-MS/MS Method for the Quantification of OAT1 Biomarkers

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M1230-04-025 - Liver metabolomics in Mice with Erythropoietic Protoporphyria

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W1030-03-021 - Lot-to-lot Comparison and Long-term Stability of the IDS-iSYS Growth Hormone and Insulin-like Growth Factor-1 Immunoassays for Clinical Trial Support

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T1130-04-027 - Measurement of Protein X by LC-MRM/MS Using the AQUA Approach in Dissected FFPE Breast and Gastric Tumor Tissue

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M1330-03-018 - Measurement of Squalene in Human Plasma by UPLC-APCI-MS/MS

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T1030-03-018 - Metabolite Profiling of Ceftibuten and Clavulanate following Individual and Combined Oral Administration to Healthy Subjects to Evaluate Potential for Drug-Drug Interaction

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T1330-04-029 - Method Development for Bioanalysis of Efavirenz using HPLC-MS

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T1130-03-022 - Method Performance Assessment during Clinical Development to Support Robust Method Development for Late Stage Biologics Programs

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M1130-04-028 - Method Validation of Quantitation IL-17A in Human Serum Using the Ultrasensitive Quanterix Simoa™ Platform

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M1130-03-019 - Mitigation of Non-Specific Binding of Master Mix Reagents in a CDX-301 Anti-Drug Antibody Assay

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T0930-04-030 - Modern LC-MS/MS-based proteomics: Powerful tools for reliable discovery of biomarkers and biomedical mechanisms in drug development

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W1030-04-025 - Multifactorial Troubleshooting and Corrective Action for the Use of Hamilton Automation in Preparation of Plate Acceptance Quality Control Samples in Non-Clinical and Clinical PK Method Development

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T1430-03-021 - Neurite outgrowth from PC12 cells in presence of nanoparticle covered carbon nanotubes: potential to develop a novel nanoparticle based therapeutic approach?

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M1530-04-025 - New Immunoassay Platforms: A Practical Guide to Method Validation

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T1430-03-017 - Non-arrhenius Behavior of Peptide Fibril Formation in the Presence of Stabilizing Excipients and Its Impact on Formulation Development

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W1230-04-027 - Optimization and Development of an Oligonucleotide Hybridization ELISA for the Quantitative Detection of a Therapeutic Aptamer in Human Plasma

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M1130-03-021 - Optimization of Sensitivity and Drug Tolerance in a CDX-1140 Anti-Drug Antibody Assay Using Split-Plot Design of Experiment.

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M0930-03-017 - Optimized Extraction and MFLC-MS/MS Analysis of the Antibody Drug Conjugate SigmaMAb Extracted from Rat Plasma

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T1130-04-029 - Overcoming Challenges in ADA Assay Development

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W0930-04-026 - Overcoming Matrix Effect: Development and Validation of an LC-MSMS Assay for the Quantitation of a Clinical-Stage Monoclonal Antibody (mAb) in Human Urine

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W1230-04-028 - Passive Permeability of the Blood-Brain Barrier to [13C]Sucrose Compared in Young Male and Female Mice

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M1530-04-026 - Patient-Specific Fluorescence Aberration Profiles During Longitudinal Clinical Trials

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W1130-04-029 - PD-1-Positive Population in Resting T Cells Identified Using a Qualified Flow Cytometric Method

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T1030-04-025 - Peptide Mimetics for Pharmacokinetic Analysis of Monoclonal Antibody Therapeutics

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T1330-04-028 - PHARMACOKINETICS OF NOVEL ORGANIC CARBON MONOXIDE PRODRUG BW-CO-103

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M1030-03-018 - Photo-curable Hyaluronic Acid Hydrogels for Encapsulation and Tissue Engineering of Human Dental Pulp Stem Cells

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T1130-03-023 - Potency Assessment of an Antibody Drug Conjugate Using a Dual Approach: Measurement of Specific Binding of Antibody Component and Cytotoxic Efficacy of Drug Conjugate

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T1130-04-028 - Preclinical Immunogenicity Assessment of Therapeutic Proteins and Antibodies: Applications of a Novel ADA Assay Platform based on Capillary Electrophoresis and Immunodetection

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T1130-03-017 - Preparation and Characterization of Poly(2-ethyl-2-oxazoline)-Lipid Conjugate as an Alternative to Polyethylene Glycol (PEG) for Surface Modified Long Circulating Liposomes

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T1130-03-019 - Preparation, Evaluation and In Vitro Characterization of a New 8-aminoquinoline Derivative Loaded Nanostructured Lipid Carriers and Nanoemulsion for Relapsing Malaria

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T1130-03-021 - Prevention of Cerebral Ischemia/Reperfusion Injury by Neutrophil-Derived Nanovesicles

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M1530-03-018 - Qualification of a Simultaneous Extraction of Ceftibuten and Clavulanate from Dog Plasma for Analysis by LC-MS/MS to Support Pharmacokinetic Studies

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W1130-04-027 - Qualification of an IFN-gamma Elispot Assay in the Bioanalytical Laboratory

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T0930-04-026 - Quantification a Phase II Metabolite in Dog Plasma without Reference Standard Material by LC/MS/MS

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M1230-03-019 - Quantification of Doxorubicin in Rabbit Liver Tumor Samples after Near Infrared Mediated Photochemotherapy Using HPLC Assay with Fluorescenc Detection

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W0930-03-021 - Quantification of human IgG in F12 fermentation medium without sample preparation using Flow induced dispersion analysis (FIDA)

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M1230-04-026 - Quantification of Intracellular Triphosphate Metabolites of Emtricitabine by LC-MS/MS.

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M1430-03-021 - Quantification of Zolpidem in Human Plasma Using LC-MS/MS

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T1030-04-030 - Quantitation and Metabolic Profiling of siRNA in Biological Matrices by Liquid Chromatography and High Resolution Accurate Mass (LC/MS-HRAM) Mass Spectrometry

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M1330-04-026 - Quantitation of 17-β-Estradiol using a very sensitive and high-throughput LC-MS/MS assay: Application to guinea pig pharmacokinetic study

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W1030-03-019 - Quantitation of Anti-Sense Oligonucleotides in Biological Samples Using a One-Step SPE Method and LC-MS/MS

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T1430-03-018 - Quantitation of Four Chiral Drug Compounds Simultaneously Using Normal Phase LC-MS/MS Equipped with an APPI Ion Source

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W0930-03-019 - Quantitation of the Monoclonal Antibody Rituximab Using Volumetric Absorptive Microsampling, Impact-Assisted Extraction, Trypsin Digestion and LC-MRM

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T1330-03-020 - Quantitative Raman Microanalysis of Drug and Lipid Accumulation in Pulmonary Alveolar Macrophages

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M1430-04-029 - Rapid LC-MS/MS Assay for CER1, an Essential Omega-O-acylceramide in Primary Human Keratinocytes

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T1230-03-018 - Redefining Distribution: Immunogenicity Screening Cut Point Determination via Shapiro-Wilk and Skewness

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W1030-04-026 - Remicade Stabilization with Hydroxypropyl-ß-Cyclodextrins

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M1530-03-019 - Selective Quantitation of 1,3-Propanediol in Dog Plasma Using Differential Ion Mobility Spectrometry

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T1330-04-026 - Sensitive LC-MS/MS method for determination of doxorubicin and its metabolite, doxorubicinol, in mouse plasma: Application to determination of new formulation of doxorubicin’s cardiotoxicity in mice

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M1430-04-028 - Serological Epidemiology of Cytomegalovirus in Pregnant Women Attending at Maternity Lucrécia Paim, Luanda, Angola

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T1230-04-027 - Seroprevalence of Rubella Virus in Pregnant Women Attending at Maternity Lucrécia Paim, Luanda, Angola

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T1030-03-022 - Simultaneous Determination of Dexmedetomidine and Its Two N-glucuronides in Adult Critically Ill Patients

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T0930-04-025 - Simultaneous Determination of Donepezil and Its Three Active Metabolites in Rat Plasma and Brain by LC-MS/MS

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M1230-04-027 - Simultaneous determination of intracellular concentrations of tenofovir, emtricitabine, and dolutegravir in human brain microvascular endothelial cells using LC/MS-MS

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T1530-03-018 - Singlicate Analysis: Should This Be the Default for Biomarker Measurements Using Ligand Binding Assays?

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M1030-04-027 - Slow Off-Rate Modified Aptamer (SOMAmer) as a Novel Reagent in Immunoassay Development for Accurate Soluble Glypican-3 Quantification in Clinical Samples

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M1130-04-030 - Smart Polymer Reagents for Bioanalytics and In Vitro Diagnostics

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M0930-04-025 - Specific Identification for Capto Family Chromatography Resins by FTIR and Particle Size Analysis

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M0930-03-019 - Specific Quantitation of Antisense Oligonucleotides in Plasma Using MSD® Electrochemiluminescence, Hybridization-Based ELISA, and HPLC-MS/MS Platforms

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T0930-03-019 - Stability of Diluted Neuromuscular Blocking Agents Utilized in Perioperative Hypersensitivity Evaluation

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T1430-03-022 - Study of Multi-Walled Carbon Nanotubes in Lung Tissue Using a Combined Hyperspectral Imaging Technique

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M1030-04-025 - Supporting Clinical Trials: The Impact of Sample Preparation on the Quality of Immunology Data

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M1030-03-020 - Surface Modification of Gemcitabine-Incorporated Acid-Sensitive Micelles Increases Their Cytotoxicity against Macrophages and Tumor Cells

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T1430-04-029 - Synthesis and Characterization of Tellurium Nanoparticles with Antimicrobial and Anticancer Properties made by Green Synthesis with Orange ,Lemon , and Lime Extract

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M1030-03-021 - Synthesis and Characterization of Temozolomide Loaded Oleic Acid Magnetic Nanoparticles for Treatment of Glioblastoma Multiforme

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W0930-03-022 - TANDEM UHPLC OPERATION FOR HIGH-THROUGHPUT LC-MS PEPTIDE MAPPING ANALYSES

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T1430-03-019 - The Determination of Human PBMC Counts Using a Genomic DNA Standard with Fluorescent Quantitation

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W1030-04-027 - The Elusive Labile Iron: Bioanalytical Techniques to Measure Iron Speciation in Human Plasma

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T1230-04-026 - Toxoplasmosis and Pregnancy in Luanda, Angola

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T1130-03-020 - Ultra Sensitive PK Bioanalysis in Support of the Development of a Bispecific Immune-Recruiting Biotherapeutic

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T1530-04-028 - Ultra-Sensitive Double Immunocapture-LC/MS Assay for Quantitation of a Therapeutic Protein in Monkey Plasma and Ocular Matrices

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T1530-04-026 - Understanding of Protein Adsorption to Interfaces Using Sum Frequency Generation Spectroscopy: Effects of Interfacial Interactions on Protein Conformation and Drug Product Stability

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M1230-03-017 - Use of Alternative Mobile Phase Additives to Improve Reverse Phase HPLC-MS/MS Sensitivity

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W0930-04-028 - Use Photo-Reactive Excipients to Detect Peptide-Matrix Interactions in Lyophilized Solid

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W1230-03-020 - Utilizing High-Content Human Protein Microarrays to Identify Potential Biomarkers for Hypertrophic Cardiomyopathy

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M1530-04-027 - Validation of a Research Use Only Flow Cytometric Assay for Clinical Diagnostic Implementation: HLA-DR Expression on Monocytes

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M0930-03-020 - Validation of an IC - LC-MS/MS Method for the Quantification of Insulin Aspart in Human Plasma and Serum

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Clinical Pharmacology
T1230-05-033 - A Comprehensive and Systematic Review of Gastric pH and Factors Affecting Gastric Fluid Volume Dynamics under Fasted and Fed Conditions in Humans

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M1030-05-036 - A First-Iin-Human Trial Comparing Pharmacokinetics, Pharmacodynamics and Safety of Cannabis Following Multiple, Ascending Doses of Dried Tablets Delivered by Smoking Inhalation

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M1330-05-034 - A Hybrid PBPK/PD Model for the Effect of Antibody Binding Site Barriers on Antibody Tumor Growth Inhibition in Preclinical Animal Studies

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M1430-05-039 - A Joint Model Describing Gastric Emptying Driven Pharmacokinetics of Losartan and Its Active Metabolite EXP-3174 Based on Data from Two Bioequivalence Studies

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M0930-05-034 - A Pharmacokinetic Evaluation of Dabigatran Etexilate, Total Dabigatran, and Unconjugated Dabigatran from Dabigatran Etexilate Mesylate Capsules in Healthy Subjects

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T1330-05-033 - A Pharmacokinetic Evaluation of Fluticasone Furoate Given Intranasally in Healthy Subjects Using an Ultra-Sensitive Analytical Assay

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W1230-05-039 - A Physiologically Based Pharmacokinetic Model of Rivaroxaban: Role of OAT3 and P-gp Transporters in Renal Clearance

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M1430-05-035 - A Preclinical Population Pharmacokinetic Model for INBRX-101, a Recombinant Human AAT-Fc Fusion Protein

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W1230-05-035 - A Preliminary Quantitative System Pharmacology Model of Chimeric Antigen Receptor T cell Therapy in Cancer Patients

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T1030-05-040 - A Retrospective Investigation of Post-Complete Response Letter (CRL) Meeting Requests (MRs) Related to Bioequivalence Assessment in Abbreviated New Drug Applications (ANDAs)

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T1130-05-036 - A Semi-Physiological Modeling and Simulation Approach for Guided Decision Making in R&D

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M0930-05-035 - Altered Pharmacokinetics in Prolonged Infusions of Sedatives and Analgesics Among Adult Critically Ill Patients: A Systematic Review

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W0930-05-033 - An Evaluation of the Pharmacokinetics of Abiraterone Acetate and Abiraterone following a Single-Dose Administration of Abiraterone Acetate 250 mg Tablets to Healthy Subjects

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T0930-05-033 - An Evaluation of the Pharmacokinetics of Tiotropium following a Single-Dose Inhalation in Healthy Subjects Using an Ultrasensitive Bioanalytical Method

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M1430-05-040 - AR-42 Pharmacokinetics: Estimated versus Measured Patient Body Composition

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T1530-05-033 - Assessing the Role of Intracellular Binding Protein in Drug-Induced Bile Acid Transporter Inhibition Using Quantiative Systems Pharmacology (QSP) Modeling

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T1030-05-036 - Assessment of Bioavailability of Diclofenac from Two Topical Drug Products using Pharmacokinetic and Skin (Tape) Stripping Analyses

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T1030-05-033 - Assessment of Factors Affecting Intrasubject Variability of Drugs Evaluated for Bioequivalence

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M1030-05-033 - Assessment of Local and Systemic Bioavailability of Lidocaine from Two Lidocaine Topical Delivery Systems using Pharmacokinetic and Skin (Tape) Stripping Analyses

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T1530-05-034 - Assessment of Pharmacokinetic (PK) Comparability Studies on Prefilled Syringes (PFS) and Autoinjectors(AI) for Biological Products

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M1230-05-033 - Automated Average Bioequivalence Analysis with Additional Metrics and Statistics to Meet the FDA guidance on Methylphenidate Hydrochloride Using Phoenix® WinNonlin®.

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M1030-05-038 - Awareness, Attitude, and Knowledge toward Oral Contraceptive Use Among Korean Women

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T0930-05-035 - Capturing, Counting and Identifying CECs: A Potential Diagnostic Marker for Patients with Pulmonary Arterial Hypertension

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M0930-05-037 - Characteristics of the Luminal Environment in the Lower Intestine of the Elderly which are Relevant to Drug Absorption and Comparison with the Adult Population

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M1530-05-035 - Characterization of Plasma Membrane Localization and Phosphorylation Status of Organic Anion Transporting Polypeptide (OATP) 1B1 c.521 T>C Polymorphism

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T1430-05-035 - Clinical Pharmacokinetic Study of Olmesartan/Amlodipine/Rosuvastatin Fixed-Dose Combination Tablet

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W1130-05-038 - Common Bioequivalence Deficiencies in Abbreviated New Drug Applications (ANDA) of Transdermal Delivery System (TDS) Products

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T1430-05-037 - Comparison of the Pharmacokinetics of Four Different Dose-Frequency Combinations of AMZ001 (Diclofenac Gel 3.06%) with Voltaren® (Diclofenac Gel 1%) in Healthy Subjects in a Phase 1 Study

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W0930-05-034 - Could SNPs Predict Cisplatin Toxicity?

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M1030-05-034 - Could Toxicities and Oxidative Stress Due to Cisplatin be Ameliorated with the Use of Acetylcysteine without Decreased Antitumor Efficacy? A Randomized Double-Blind Placebo-Controlled Trial

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M1530-05-039 - Developing a 3-D Cell Culture Model of Chemically Induced Oral Mucositis

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T0930-05-036 - Development and Evaluation of a New Aspirin Formulation

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M1230-05-035 - Development and Validation of a PBPK Model to Predict Plasma and Sputum Exposures after IV, Oral or Inhalation Administration of Ciprofloxacin in Healthy Volunteers and Cystic Fibrosis Patients

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M1230-05-037 - Development and Verification of Population Level IVIVC Using Mechanistic PBPK Modeling for Trazodone Extended Release Formulations to Support Biowaiver for SUPAC Changes to the Formulation

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W1030-05-034 - Development of a Microfluidic Cell Culture Platform for High Throughput Quantitative Drug Screening

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M1430-05-033 - Development of a Population Pharmacokinetic Model to Characterize Cocaine and Metabolites Behavior in Mice

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W1230-05-038 - Development of an Ocular Physiologically-Based Pharmacokinetic Model to Describe the Impact of Formulation Attributes on the Disposition of an Antibiotic Applied on the Rabbit Eye

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T1130-05-035 - Development of In Vitro In Vivo Correlation Model for Testosterone Transdermal Gel Product

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W1030-05-037 - Development of the Lipid Nanoparticles Loaded with Immunostimulatory Oligodeoxynucleotide for Cancer Therapy

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W1130-05-034 - Disease Progression Modeling of Placebo-response in Analgesic Clinical Trials

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M1530-05-037 - Do Uremic Solutes Potentially Affect UDP-Glucuronosyltransferase (UGT) Enzymes?

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M1130-05-037 - Droplet Evaporation from a Solution-Based Metered Dose Inhaler: A Computational Approach

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W1230-05-033 - Drug-Induced TMDD: A Novel Class of PK Models for Immune-Stimulating Therapies

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M1530-05-034 - Effect of a Common Genetic Variant (p.V444A) in the Bile Salt Export Pump on the Kinetics and Inhibition of Bile Acid Transport by Cholestatic Medications

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T1430-05-036 - Effect of Adhesion on Pharmacokinetics (PK) of Transdermal (TDS) Topical Products

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M1130-05-036 - Effect of Counseling on Cost Effectiveness Analysis in Diabetes Mellitus Patients

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W0930-05-036 - Effect of CYP2D6 Genetic Polymorphism on the Pharmacokinetics of Zolpidem

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M0930-05-033 - Evaluation of Dermal Open Flow Microperfusion (dOFM) as a General Methodology to Assess the Bioequivalence of Hydrophobic, Protein-Bound Topical Drug Products

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W1130-05-036 - Evaluation of Pain from Microneedle Use in the Oral Cavity of Human Volunteers

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W1030-05-033 - Evaluation of Reapplication and Controlled Heat Exposure on Oxybenzone Permeation from Commercial Sunscreen Using Excised Human Abdominal Skin

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T1330-05-035 - Exosomes as Delivery Vehicles for Biomolecules

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W1230-05-036 - Extended Physiologically-Based Pharmacokinetics (PBPK) Modeling Approach for Effects of Obesity

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T1130-05-034 - Extracellular Matrix Softening Promotes SH-SY5Y Neuroblastoma Softening and Actin Depolymerization to Selectively Increase Abeta(1-42) Endocytosis

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T1530-05-038 - Formation of Primaquine-5,6-orthoquinone, the Putative Active and Toxic Metabolite of Primaquine via Direct Oxidation in Human Erythrocytes

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T1130-05-033 - GAA-iTEM, an In Silico Personalized Prediction Tool to Identify Infantile Pompe Disease (IPD) Patients at High Risk of Developing Anti-drug Antibodies (ADA)

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M1430-05-037 - Gastrointestinal Transit Kinetics of Cefaclor and Cefadroxil in Cystic Fibrosis (CF) Patients and Healthy Volunteers Compared via Population Pharmacokinetics

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M1330-05-037 - General Pharmacokinetic Features of Small Molecule Compounds Exhibiting Target-Mediated Drug Disposition (TMDD)–A Simulation-Based Study

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T0930-05-037 - Generic Transdermal Drug Delivery System (TDDS): Region-Specific Requirements

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T1030-05-039 - Histological Evaluation of Obstructed Insulin Pump Catheters Explanted from Patients

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M1330-05-036 - HTPK: Conducting PK Modeling and Simulations at High Speed

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T1130-05-038 - Importance of Physiologically Based Pharmacokinetic (PBPK) Modeling Approaches for Development of Dissolution Method; To Learn from Clinical Non-bioequivalent (BE) Data

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M1530-05-038 - In Vitro Evaluation of Metabolism-Based Drug Interactions with Sunscreen Ingredients

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W1230-05-037 - In Vitro to In Vivo Extrapolation (IVIVE) of Itraconazole Precipitation using a Biphasic Dissolution Test and Mechanistic Absorption Model

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M1130-05-033 - In Vivo Pharmacokinetics of Levofloxacin Niosomes

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M1330-05-033 - Inferring Target Occupancy from Fitting Nonlinear-PK Data with Mechanistic PKRO Model for Pembrolizumab

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W1030-05-039 - LC-MS/MS Method Validation of Loperamide Hydrochloride for an In Vitro Transporter Assay

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T1530-05-036 - Liver Safety Comparison of Two Treatments for Autosomal-Dominant Polycystic Kidney Disease (ADPKD) Using Quantitative Systems Toxicology Software (DILIsym)

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T1230-05-036 - Mechanistic Prediction of Effect of P-glycoprotein Inhibition on Oral Absorption and Disposition of Vemurafenib into the Brain Using IVIVE-PBPK

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M1330-05-035 - Modeling of the Antihypertensive Effect of Irbesartan and Hydrochlorothiazide Combination

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M1230-05-036 - Multi-Phase Multi-Layer Mechanistic Physiologically Based Pharmacokinetic Dermal Absorption Model Verification including Inter and Intra Individual Variability Assessment Using Nicotine as Model Drug

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W1030-05-035 - Neuroprotection by Activation of a TrpV1 Receptor Using Resiniferatoxin, against 6-OHDA Induced Toxicity and Revealing TrpV1 Mediated Pathway for Neurotrophic Activity in Neurodegenerative Disorders

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T1530-05-039 - P-Glycoprotein Drug Interaction Risk Assessment Based on In Vitro Data; Comparison of a Vesicle- Versus a Cell-Based Assay

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M1130-05-035 - Pharmacokinetic Modeling of the Effect of Recombinant Human Hyaluronidase (rHuPH20) in Subcutaneous Absorption

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W0930-05-035 - Pharmacokinetics Interaction between Metformin Hydrochloride 1500 mg and Rosuvastatin 20 mg in Healthy Subjects

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T1330-05-036 - Pharmacokinetics, Safety and Efficacy of Solid Lipid Boswellia serrata Particles (SLBSP) For Symptomatic Treatment of Osteoarthritis of Knee.

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T1030-05-035 - Pharmacokinetics/Pharmacodynamic Studies of Metformin in a Phase I Dose-Escalation Study in Locally Advanced Head and Neck Squamous Cell Carcinoma Patients

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M1530-05-033 - Photochemical Internalization to Improve the Therapeutic Indices of Chemotherapy Drugs

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T1230-05-038 - Physiologically Based Pharmacokinetic Modeling of Carvedilol in CYP2D6 Genetic Polymorphism

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T1130-05-039 - Physiologically Based Pharmacokinetic Modeling of Tamsulosin in relation to CYP2D6 genetic polymorphism

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T1030-05-034 - Plasmatic and Urinary Biomarkers of Oxidative Stress and Toxicities Induced by Cisplatin in Head and Neck Cancer Patients

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W1230-05-034 - Population Pharmacokinetic-Pharmacogenetic study of atazanavir/ritonavir in Thai HIV-infected patients

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M1430-05-034 - Population Pharmacokinetics of Durvalumab Following Combination Therapy with Olaparib in SCLC, Ovarian, Breast and Gastric Cancer Patients

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M1430-05-036 - Population Pharmacokinetics of Rituximab in Membranous Nephropathy

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M1430-05-038 - Population Pharmacokinetics of Subcutaneously- and Intradermally- Administered Glucagon in Type 1 Diabetic Patients

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W1130-05-037 - Preclinical activity and pilot phase I study of pacritinib, an oral JAK2/FLT3 inhibitor, and chemotherapy in FLT3-ITD+ AML

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T1030-05-038 - Pre-Clinical and Clinical Assessment of Letrozole Steady-State Pharmacokinetics in Malignant Gliomas: Application of Physiologically-Based PK Modeling to gain Quantitative and Mechanistic Insights

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T1230-05-037 - Predicting Depth Resolved Concentrations in the Dermis using PBPK modelling: Design, development and verification of the model with five drugs

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W1030-05-038 - Proteasome Inhibitors Bortezomib and Carfilzomib Stimulate the Transport Activity of Human Organic Anion Transporter 3

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M1130-05-034 - Reference-Scaled Average Bio-Equivalence (SABE): A Promising Statistical Approach to Analyze Cutaneous Pharmacokinetic Results for Topically Applied Drug Products

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W1030-05-036 - Regulation of Human Organic Anion Transporters 3 by Protein Kinases A: Crosstalk between Sumoylation and Ubiqitination

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T1030-05-037 - Relative Bioavailability, Effect of Food, Gender Difference, Safety, and Tolerability of Etrasimod, a Next-Generation, Oral, Selective Sphingosine 1-Phosphate Receptor Modulator, in Healthy Subjects

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T1330-05-037 - Review of Substrates and Inhibitors Used in Transporter-Mediated Clinical Drug-Drug Interaction Studies

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M0930-05-036 - Safety, Pharmacokinetics and Pharmacodynamics of CNTO 7160, an Anti-IL-33R Monoclonal Antibody, in a First-in-Human Study in Healthy Subjects, Subjects with Asthma, and Subjects with Atopic Dermatitis

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T1230-05-034 - Tackling Ineffective Metformin Dosing in Type 2 Diabetic Children Using a Physiologically-Based Pharmacokinetic Model and Individualized Dosing

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T0930-05-034 - The effects of Warfarin long use in quality of life and treatment adherence in patients with Primary Antiphospholipid Syndrome.

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T1430-05-033 - The efficacy and safety effects of Cordyceps militaris extract supplement (D.C. Daily®) in vivo models and clinical trial

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M1530-05-036 - Transplacental Transfer of Doxorubicin and Doxil® (PEGylated Liposomal Doxorubicin) across BeWo b30 Trophoblast Cell Monolayers

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T1130-05-037 - Understanding the Impact of Age-Related Changes in Paediatric Gastrointestinal Solubility by Multivariate Data Analysis

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M1230-05-038 - Updated Physiologically Based Pharmacokinetic (PBPK) Model for Acetaminophen Metabolism with an Emphasis on Phase I Metabolism

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M1230-05-034 - Use of Electronic Medical Records and a DNA Biobank to Develop a Population Pharmacokinetic Model for Tacrolimus

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T1530-05-035 - Using Visualization to Address the Reliability of Sources of Initial Parameter Values in a Quantitative Systems Pharmacology Model

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Formulation and Quality
T1230-12-092 - 4D Printing for Fabrication of Retentive Intravesical Drug Delivery Systems Based on Poly(vinyl alcohol)

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T1330-11-088 - A 14 Day Gastric Resident Oral Formulation of Ivermectin for Prevention of Malaria Transmission

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M1230-09-069 - A 3D Bioprinted In Situ Conjugated-co-Fabricated Scaffold for Bone Tissue Engineering Applications

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T1030-09-065 - A Comparative Study of Two Liposomal Delivery Systems Targeted for Glioblastoma Multiforme

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W0930-12-095 - A Comparison of Formulation Approaches for a Small Molecule with a Short Biological Half-Life for the Treatment of Irritable Bowel Syndrome (IRB)

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T1330-08-063 - A Dual Delivery System for Antibiotics and Probiotics: An In Vitro, Ex Vivo, In Vivo and In Silico Evaluation

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M1030-07-049 - A Flow-Through Dissolution Method for Evaluation of Drug Release from Manipulated Abuse Deterrent Formulations

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T1230-12-091 - A Formulation-by-Design Approach to Design and Fabricate FDM 3D-Printed Tablets with Pre-defined Release Kinetics

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M1330-07-055 - A General Practical Approach for Trace Level Determination of Arylamine Genotoxic Impurities in Drug Substances

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M1130-09-070 - A Low Volume Microfluidic Multiplexed Viscometer for Newtonian and Non-Newtonian Fluids

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M1430-13-099 - A Material-Sparing Approach for Developing Sildenafil Orally Disintegrating Tablet

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T1030-10-073 - A Mathematical Model Linking the Formation of Amorphous Solid Dispersions with Hot-Melt-Extrusion Process Parameters

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M1230-07-050 - A Mathematical Model to Determine Actual Drug Release Kinetics from Nanocarriers using Dialysis Methods

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T0930-12-093 - A Microfluidic Platform for Rapid Production of Scalable, Tunable, and Controlled Lipid Nanoparticles

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M1230-09-072 - A Modified USP Induction Port To Characterize Nasal Spray Plume Geometry And Predict Turbinate Deposition Under Flow

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T1430-10-080 - A New Excipient for Effective Taste Masking at Low Coating Levels

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W1130-13-103 - A Novel Approach for the Fabrication of Nanoparticle Agglomerates for Pulmonary Drug Delivery

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T1530-07-050 - A Novel Approach to Keloid and Hypertrophic Scar Therapy: Sustained Release of Proteases from PLGA Microspheres.

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M1030-10-074 - A Novel Architecture to Enable High Active Loading of Tablets of Amorphous Spray Dried Dispersions

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W1130-08-063 - A Novel Cyclodextrin-Based Pickering Emulsions for Prolonging the Duration of Topical Local Anesthesia

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T0930-10-079 - A Novel Solid Self-nanoemulsifying Drug Delivery System (S-SNEDDS) for Improved Stability and Oral Bioavailability of an Oily Drug, 1-palmitoyl-2-linoleoyl-3-acetyl-rac-glycerol

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T1430-07-049 - A Novel S-sulfhydrated Human Serum Albumin Preparation Suppresses Melanin Synthesis

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W1130-11-085 - A Patient-Centric Approach: Formulation of Prolonged Release Microparticles to be Used in Oral Suspensions for Older Patients with Dysphagia

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T1130-13-104 - A PBPK Model of the Negative Effect of Chitosan on Acyclovir Absorption: The Mucus-Chitosan Interaction

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M1430-11-083 - A Platform Formulation Approach for Rapid Development of Controlled Release Multiparticulates for Early Clinical Studies

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T1130-08-062 - A Promising Lyophilized Orodispersible Tablets of Ethyl Morphine Hydrochloride for Clinical Use

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M1330-07-056 - A Quality by Design Approach to Analytical HPLC Method Optimization

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T1330-12-090 - A Review of Recent Progress in GDUFA Research Program on PLGA-Based Drug Products: Three Case Studies

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M1030-10-079 - A Simple Rheological Method for Polymer Selection in Amorphous Drug Solid Dispersions

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T1130-07-051 - A Simple, Accurate and Economical Method for Quantitative Estimation of Calcium Acetate Capsules by High Performance Liquid Chromatography Using UV Detector

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W0930-09-067 - A Smart Macrophage Bioreactor for Deep Penetrating Delivery of Anti-Tumor Peptide for Breast Cancer Therapy

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T1030-11-086 - A Spectroscopic Assessment of Interaction Anisotropy in Pharmaceutical Materials: Assessing Potential Drug Candidates for Direct Compression

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M1330-11-081 - A Study of the Impact of Excipient Shielding on Initial Drug Release Using UV Imaging

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M0930-09-071 - A Systematic Approach to Formulate and Evaluate the Stability of Topical Creams with High Concentrations of Transcutol® HP

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M0930-09-070 - A Transdermal Electro-Modulated Hydrogel- Microneedle Device for Chronic Pain

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T1230-07-050 - A Validated 19F NMR Technique to Assay Quantitatively Fluorinated Synthetic Cannabinoid Agonists

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T1030-13-099 - Absorptive Dissolution Testing of Supersaturating Systems: Impact of Absorptive Sink Conditions on Solution Phase Behavior and Mass Transport

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M1230-09-070 - Abuse Deterrent Immediate Release Egg-Shaped Tablet Using 3D Printing Technology: Multifactorial Design to Optimize Release and Extraction

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M1530-11-081 - Abuse-Deterrent/Crush-Resistant (ADCR) System: A Novel In Situ Sintering Matrix

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T1430-10-075 - Acoustic Detection of Capping Risk in Solid Dosage Forms

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W0930-08-060 - Activity and Delivery of Novel mitoNEET Ligand NL-1 for Cerebral Ischemia Reperfusion Injury

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W0930-10-077 - Adsorbing the Poorly Water Soluble Drug on Porous Calcium Silicate by Sealed Heating Method

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T1530-10-077 - Advantage of Various Pellet Coating Techniques Using Hypromellose Acetate Succinate (HPMCAS)

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W1230-11-082 - Advantages of Spongy PLGA Microsphere as Parenteral Depot Injection

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T1230-10-073 - Altering Particle Size and Shape during the Precipitation of API in Aqueous Solvent Systems

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M1430-10-080 - Amorphous-Based and Crystalline-Based Solid Dispersion-An Industrial Assessment

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M0930-13-103 - An In Vitro Biorelevant Assessment of Prussian Blue

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M1130-13-101 - An Integrated Experimental and Modelling Approach to Characterize the Precipitation Kinetics of Compounds with Poor Aqueous Solubility: From In Vitro to In Vivo Predictions

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T1530-09-068 - An Investigation into the Thermal Stability of a Cocrystal Form of Hydrochlorothiazide/Nicotinamide: Thermally Induced Coamorphous Drug Forms

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T1530-07-049 - An Isolated Perfused Rat Lung Model for Studying Controlled and Targeted Release of Fasudil, an Anti-PAH Drug from Peptide Grafted Liposomal Formulations

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T1230-09-067 - Analgesic Effect of Diclofenac Sodium Loaded Dissolving Microneedle Patches in Treatment of Glacial Acetic Acid Induced Acute Inflammation in Rats

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T1530-08-062 - Antibacterial Agent Loaded Nano-lipid Carriers for the Selective Mitigation of Pathogenic Bacteria and Their Biofilms in the Skin

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M1130-08-057 - Anticancer Effects of Tannic Acid on Non-small Cell Lung Cancer

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T1030-08-060 - Antinociceptive Effects of a Multifunctional Burn Wound Dressing in Rat Model of Second Degree Burn Injury

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M1430-10-073 - API and Precipitation Inhibitor Co-Loaded Mesoporous Silica: A Novel Synergistic Formulation Type with Advantageous Dissolution Performance

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T0930-11-081 - Apparent Molal Volumes of a Non-ionic Surfactant Derived from Castor Oil in Microemulsions with Various Polar Oils

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T1230-07-053 - Application of 19F Solid-State NMR Spectroscopy for Detection of Low Levels of Crystalline Content in Amorphous Solid Dosage Forms

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M1430-07-055 - Application of 2D NMR for Structural Characterization of Monoclonal Antibodies

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W1030-09-070 - Application of 3D Printing Technology and Quality by Design Approach for the Development of Age Appropriate Formulation

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T1330-11-081 - Application of Cellulosic Polymers in Delayed Release Coating of Diclofenac Sodium Tablets

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W0930-07-055 - Application of DOSY NMR to Droplet Size Measurement for Emulsion Drug Products

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M1530-07-055 - Application of NIR to Monitor the Secondary Drying of a Spray Dried Intermediate

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W1030-13-103 - Application of QbD Principles to Late Phase Clinical Development

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W1230-11-084 - Application of Thermo-Sensitive Hydrogel for Changing the PK of PPS1D1-M to Avoid Acute Toxicity

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M1130-13-102 - Applying Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulation for Quality Risk Assessment: The Impact of Drug Substance Particle Size of BCS Class II Drug on the In Vivo Performance

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T1530-10-079 - Are Excipients Inert? Phenytoin: A Follow-up Half a Century Later with New Incompatibility Insights

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T1230-07-051 - Artificial Gut Simulator for Simultaneous Evaluation of Dissolution and Absorption of Supersaturating Drug Formulations

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T1130-11-088 - Asparagine Deamidation in the Fc Region of Therapeutic Monoclonal Antibody–Effect of Selected Mutations on Fc-Receptor Binding and Deamidation

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T1530-08-064 - Assessment of Bioavailability of Rivastigmine from Two Rivastigmine Transdermal Delivery Systems with and without Exposure to Heat Using In Vitro Permeation Test (IVPT)

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M1130-12-089 - Assessment of Compressibility and Compactibility of Pharmaceutical Powders and Their Binary Mixtures Using Percolation Theory

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M1230-11-081 - Assessment of Drug Gastrointestinal Supersaturation Using In Vitro Dissolution Absorption System 2 (IDAS2)

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T1130-07-054 - Assessment of Drug Quality Using the Regulatory Framework of the FDA-DOD Shelf-Life Extension Program to Extend the Expiration of Medical Drug Products

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M1430-12-092 - Assessment of Quality Control Parameters and In Vitro Bioequivalence/Interchangeability of Multisourced Marketed Metformin Hydrochloride Tablets in the State of Qatar

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M1530-08-063 - Assessment of Radiation Sterilization Impact on Rheological Properties and In Vitro Release Profiles of a Thermo Responsive Topical Gel

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T0930-11-084 - Assessment of the pH-Stability Profile of Epinephrine for Sublingual Administration

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W0930-10-073 - Autoclave Vial Delamination Revisited: SWFI vs. Captisol® Solutions

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W0930-07-052 - Automated Particle Count Analysis for Protein Formulation Optimization to Minimize Aggregation and Perform USP 787 Subvisible Particulate Matter Testing

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W0930-12-093 - Batch Age Effect on Potency and Pharmaceutical Quality of Brand Levothyroxine Sodium Tablets

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W0930-12-091 - Berberine Nanoparticles with Anti-Alzheimer Potential: Effect of Coating on Cerebrovascular Amyloid Targeting and Nanotoxicity in Rats

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M1030-09-068 - BergaCare SmartLipids® - Development of Commercial Concentrates of Phenylethyl Resorcinol for Skin Whitening

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W1130-07-050 - Bile Based Vesicles for Hepatocytes Specific Oral Delivery of Direct Acting Antiviral (DAA): Assessment of the Targeting Ability of the Charged and β-sitosterol Decorated Vesicles

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M1330-08-059 - Bioadhesive Nanocarrier Improve Cytotoxicity of Piplartine and Mammary Tissue Targeting by Intraductal Administration: A New Strategy for Treatment of In Situ Ductal Carconoma

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M1230-12-092 - Biodegradable Polymeric Micelles for Delivery of Irinotecan

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M1030-08-061 - Biodistribution Study of Intranasally Delivered liposomes

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T1330-08-060 - Bioengineering of Thermoreversible Hydrogels Loaded with Bone Morphogenic Protein-2

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M1430-09-067 - Biomimetic Formulation of Clofazimine Hydrochloride Microcrystals for Local Administration

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M0930-12-092 - Biomimetic Nanostructured Lipid Carrier Containing Paclitaxel Coated with Platelet Membrane

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T1430-07-051 - Bioreducible Cross-Linked Polypeptide Micelles for Enhanced Cancer Combination Therapy

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T1530-13-100 - BiPhasic Dissolution Tests Conducted at Low Buffer Capacity Conditions

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T1230-11-084 - Box-Behnken Design for the Optimization of Sustained-Release Tablet Formulation for Bupropion Hydrochloride

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T0930-08-064 - Brain Targeting of Ginsenosides Self-nanoemulsifying Drug Delivery System to Ameliorate Metabolic Syndromes and Keep Homeostatic Balance

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T1530-07-054 - Breast Cancer Chemoprevention: A New Liquid-Crystalline System for Sustained Local Drug Release

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M1130-10-073 - Built-In Quality of Cocrystal between Indomethacin and Saccharin at High Shear Granulation Process

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M0930-07-055 - Can One-Stage In Vitro Dissolution Using Water as Medium Represent Guaifenesin Release from Extended-Release Bilayer Tablets?

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M1330-10-075 - Can the Commonly used pH-Stat Titration Method be Improved Upon for Correlating Drug Release with Lipid-Based Formulation Digestion?

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T1130-07-049 - Category 1 Assessment: Vaping of Abuse Deterrent Opioid Formulations

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T1130-08-061 - Cell-Penetrating Peptide Enhances Efficacy of Paclitaxel Nanomicelles in Traditional 2D Monolayer Culture and Multicellular Tumor 3D Spheroids of Triple Negative Breast Cancer Cells

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M1130-09-072 - Challenges Encountered in Evaluating the Compatibility of Broadly Neutralizing Antibodies with Intravenous (IV) Fluids

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T1030-07-052 - Characterization and Quantification of Five Synthetic Cannabinoid Agonists (SCA) Using NMR and UHPLC-QTOF/MS/MS

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T1130-10-074 - Characterization of API Bulk Properties to Identify Quality Attributes to Support Formulation of Drug Product

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M1330-08-060 - Characterization of Drug-Loaded Milled Extrudate Particles Produced by Hot Melt Extrusion Technology for Dry Powder Inhalers

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W0930-08-061 - Characterization of GLUT-1 Targeted Nanoparticles for Drug Delivery to Brain for Treatment of Alzheimer’s Disease

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M1130-11-081 - Characterization of Lyophilized Cake Appearance and Compressive Strength

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W1230-10-076 - Characterization of SeaGel® Films for Soft-shell Capsule Applications

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M0930-09-065 - Characterization, Formulation and Topical Delivery of Terbinafine

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M1530-09-067 - Characterizing the Nature and Strength of Drug-Polymer Complexes in Aqueous Solution Using Analytical Ultracentrifugation

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T1230-13-097 - Clay-Polymer Nanocomposites Prepared by Reactive Melt Extrusion for Sustained Drug Release

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M0930-08-059 - Coated PLGA-Bevacizumab Implants for Long-Acting Anti-VEGF Efficacy in a Rabbit Retinal Vascular Leakage Model

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M1530-09-065 - Cocrystal Dissolution into Constant pH Media: Model Analysis

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T1430-09-072 - Cocrystal Superior Dissolution Performance and the Role of Supersaturation Index in Biorelevant Media

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W0930-11-083 - Co-extruded Fixed Dose Combination Products with Enabled Properties for the Treatment of Cardiovascular Diseases

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T0930-13-098 - Cold Flow Properties of Tulobuterol Patches

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T1230-11-083 - Colon Targeted Multiple Unit Pulsatile Drug Delivery of Ketoprofen - Eudragit® FS100 Pellets Prepared via Hot Melt Extrusion Technology

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T1130-11-084 - Colon-Targeted Lipase Releasing Microparticles for the Prevention of Diarrhea and Steatorrhea

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T0930-13-100 - Common Deficiencies in the Validation of Regulatory Analytical Procedures for ANDA Supplemental Applications

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