Mechanistic Modeling of In Vitro Skin Permeation and Extrapolation to In Vivo for Topically Applied Metronidazole Drug Products Using a Physiologically Based Pharmacokinetic Model-Reference-Cited by-同舟云学术

Mechanistic Modeling of In Vitro Skin Permeation and Extrapolation to In Vivo for Topically Applied Metronidazole Drug Products Using a Physiologically Based Pharmacokinetic Model

Published:2022-08-15 Issue:9 Volume:19 Page:3139-3152
ISSN:1543-8384
Container-title:Molecular Pharmaceutics
language:en
Short-container-title:Mol. Pharmaceutics

Author:

Arora Sumit¹^ORCID,Clarke James¹^ORCID,Tsakalozou Eleftheria²,Ghosh Priyanka²,Alam Khondoker²,Grice Jeffery E.³,Roberts Michael S.³⁴,Jamei Masoud¹^ORCID,Polak Sebastian¹⁵

Affiliation:

1. Certara UK Ltd, Simcyp Division, Sheffield S1 2BJ, U.K.

2. Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration (FDA), Silver Spring, Maryland 20993, United States

3. Therapeutics Research Centre, Diamantina Institute, University of Queensland, Brisbane 4102, Australia

4. Clinical and Health Sciences, University of South Australia, Adelaide 5005, Australia

5. Faculty of Pharmacy, Jagiellonian University Medical College, Medyczna 9, Kraków 30-688, Poland

Funder

National Health and Medical Research Council

U.S. Food and Drug Administration

Publisher

American Chemical Society (ACS)

Subject

Drug Discovery,Pharmaceutical Science,Molecular Medicine

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.molpharmaceut.2c00229

Reference48 articles.

1. Changes in Retail Prices of Prescription Dermatologic Drugs From 2009 to 2015

2. Innovation for Generic Drugs: Science and Research Under the Generic Drug User Fee Amendments of 2012

3. A new paradigm for topical generic drug products: Impact on therapeutic access

4. Generic Development of Topical Dermatologic Products: Formulation Development, Process Development, and Testing of Topical Dermatologic Products

5. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). The Use of Physiologically Based Pharmacokinetic Analyses-Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls Guidance for Industry. October 2020. https://www.fda.gov/media/142500/download (accessed Feb 15 2021).

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