Bioanalytics – Chemical
2018 PharmSci 360
For emerging therapeutic modalities like nucleic acid therapeutics, gene therapy, cell therapy, including the delivery mechanisms the established methods and guidance's are not always directly applicable. As there are no specific guidance’s available yet, hence, in current practice a subset of small and large molecule guidance for Bioanlayis and DMPK characterization and a combinatorial approach is utilized. This session will review the methods utilized and regulatory considerations.