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

• Главные авторы: Eleftheria Tsakalozou (Автор), Andrew Babiskin (Автор), Liang Zhao (Автор)
• Формат: ‌
• Опубликовано: Wiley, 2021-05-01T00:00:00Z.
• Предметы: article
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Abstract 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...