Guidance on the bioavailability and bioequivalence study of drug products
Changxiao Liu · Drug Evaluation Research · 2011
This is the draft version for the Guidance on the Bioavailability and Bioequivalence Study of Drug Products in China Pharmacopoeia,2015 Edition.It includes the introduction,design,conduct and evaluation of bioequivalence studies for immediate release formulations with systemic action,study report,bioequivalence study requirements for different dosage forms, and biowaiver based on biopharmaceutics classification system (BCS).In comparison to the current guidance, the bioanalytical method is separated as a discrete guidance,and new recommendations are provided for the selection of reference product,strength to be investigated parent compound or metabolites, and bioequivalence of highly variable drugs.The importance of in vitro dissolution tests is highlighted and the BCS-based biowaiver is introduced.