A mechanistic physiologically based model to assess the effect of study design and modified physiology on formulation safe space for virtual bioequivalence of dermatological drug products

A mechanistic physiologically based model to assess the effect of study design and modified physiology on formulation safe space for virtual bioequivalence of dermatological drug products

Physiologically based pharmacokinetic (PBPK) models are widely accepted tools utilised to describe and predict drug pharmacokinetics (PK). This includes the use of dermal PBPK models at the regulatory level including virtual bioequivalence (VBE) studies. The current work considers the Topicort® Spra...

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Bibliographic Details
Main Authors: J. F. Clarke, K. Thakur, S. Polak
Format: Article
Language:English
Published: Frontiers Media S.A. 2022-12-01
Series:Frontiers in Pharmacology
Subjects:
PBPK absorption model
dermal absorption
bioequivalence
virtual bioequivalence (VBE)
safe space
topical formulations
Online Access:https://www.frontiersin.org/articles/10.3389/fphar.2022.1007496/full

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