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Modeling and Simulation of Biopharmaceutical Performance
Author(s) -
Zhang X,
Lionberger R A
Publication year - 2014
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2014.40
Subject(s) - biopharmaceutical , bioequivalence , bioavailability , dosing , food and drug administration , drug , pharmacology , consistency (knowledge bases) , biochemical engineering , medicine , computer science , risk analysis (engineering) , business , microbiology and biotechnology , engineering , artificial intelligence , biology
Biopharmaceutical performance refers to the influence of pharmaceutical formulation variables on in vivo performance. New drug product success depends on formulation design for sufficient bioavailability for clinically desired dosing. Regulatory interest in biopharmaceutical performance includes batch‐to‐batch consistency, acceptability of postapproval changes, and evaluation of bioequivalence (BE) for generic drug products. This Commentary summarizes biopharmaceutical modeling and simulation in the US Food and Drug Administration (FDA) Office of Generic Drugs (OGD) for orally administered generic drugs.