Physiologically-Based Pharmacokinetic Modeling to Support Determination of Bioequivalence for Dermatological Drug Products: Scientific and Regulatory Considerations

• Published in: Clinical pharmacology and therapeutics Vol. 111; no. 5; p. 1036
• Main Authors: Tsakalozou, Eleftheria, Alam, Khondoker, Babiskin, Andrew, Zhao, Liang
• Format: Journal Article
• Language: English
• Published: United States 01.05.2022
• Subjects: Biological Availability; Computer Simulation; Humans; Models, Biological; Pharmaceutical Preparations; Therapeutic Equivalency

Physiologically-based pharmacokinetic (PBPK) modeling and simulation provides mechanism-based predictions of the pharmacokinetics of an active ingredient following its administration in humans. Dermal PBPK models describe the skin permeation and disposition of the active ingredient following the app...