Physiologically‐Based Pharmacokinetic Modeling to Support Determination of Bioequivalence for Dermatological Drug Products: Scientific and Regulatory Considerations-Reference-Cited by-同舟云学术

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

Published:2021-07-29 Issue: Volume: Page:
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin Pharmacol Ther

Author:

Tsakalozou Eleftheria¹,Alam Khondoker¹,Babiskin Andrew¹,Zhao Liang¹

Affiliation:

1. Division of Quantitative Methods and Modeling (DQMM) Office of Research and Standards (ORS) Office of Generic Drugs (OGD) Center for Drug Evaluation and Research (CDER) US Food and Drug Administration (FDA) Silver Spring Maryland USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.2356

Reference100 articles.

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4. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER).Physiologically Based Pharmacokinetic Analyses — Format and Content Guidance for Industry. Finalized September 2018 . Accessed April 3 2020.

5. European Medicines Agency: Guideline on the reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation. 13 December 2018EMA/CHMP/458101/2016 Committee for Medicinal Products for Human Use (CHMP) . Accessed April 3 2020.

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