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Physiologically‐based pharmacokinetic modeling to support bioequivalence and approval of generic products: A case for diclofenac sodium topical gel, 1%

Establishing bioequivalence (BE) for dermatological drug products by conducting comparative clinical end point studies can be costly and the studies may not be sufficiently sensitive to detect certain formulation differences. Quantitative methods and modeling, such as physiologically‐based pharmacok...

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Bibliographic Details
Published in:CPT Pharmacometrics Syst Pharmacol
Main Authors: Tsakalozou, Eleftheria, Babiskin, Andrew, Zhao, Liang
Format: Artigo
Language:Inglês
Published: John Wiley and Sons Inc. 2021
Subjects:
Online Access:https://ncbi.nlm.nih.gov/pmc/articles/PMC8129718/
https://ncbi.nlm.nih.gov/pubmed/33547863
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1002/psp4.12600
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