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Clin Pharmacol Ther. 2014 May;95(5):480-2. doi: 10.1038/clpt.2014.40.

Modeling and simulation of biopharmaceutical performance.

Author information

1
Office of Generic Drugs, US Food and Drug Administration, Rockville, Maryland, USA.

Abstract

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.

PMID:
24747237
DOI:
10.1038/clpt.2014.40
[Indexed for MEDLINE]

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