Clinical Pharmacology – Chemical
2018 PharmSci 360
Physiologically-based pharmacokinetic (PBPK) modeling may predict or describe the pharmacokinetics (PK) of drugs in healthy volunteers or specific populations. Readily available software platforms, recent regulatory guidances, new in silico ADMET tools as well as an increased awareness in academic institutions all have promoted interests in expanding PBPK in model informed drug development. Thus, PBPK has become a scientifically important tool in drug development to identify drug development risks and to facilitate regulatory interactions or approvals. Verified PBPK models allow a mechanistic understanding of ADME processes, including food-effects on drug absorption, or Drug-Drug Interactions. Case examples will highlight how PBPK modeling can e.g. a) impact clinical trial designs, b) waive studies, c) inform the dosing regimen in specific populations, d) inform product labeling language. The evolving roles of physiologically-based biopharmaceutics will also be covered. The session is expected to benefit both pharmaceutical scientists in academia or the industry interested in learning about PBPK opportunities and limitations.