Office of Generic Drugs, US Food and Drug Administration, Rockville, Maryland, USA.
Clin Pharmacol Ther. 2014 May;95(5):480-2. doi: 10.1038/clpt.2014.40.
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.
生物制药性能是指药物制剂变量对体内性能的影响。新药产品的成功取决于制剂设计，以确保临床所需剂量有足够的生物利用度。监管部门对生物制药性能的关注包括批间一致性、批准后变更的可接受性，以及仿制药产品的生物等效性（BE）评价。本文概述了美国食品和药物管理局（FDA）仿制药办公室（OGD）在口服仿制药方面的生物制药建模和模拟。
