Prediction of Metabolite‐to‐Parent Drug Exposure: Derivation and Application of a Mechanistic Static Model-Reference-Cited by-同舟云学术

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Prediction of Metabolite‐to‐Parent Drug Exposure: Derivation and Application of a Mechanistic Static Model

Published:2020-02-04 Issue:3 Volume:13 Page:520-528
ISSN:1752-8054
Container-title:Clinical and Translational Science
language:en
Short-container-title:Clin Transl Sci

Author:

Callegari Ernesto¹,Varma Manthena V.S.¹,Obach R. Scott¹

Affiliation:

1. Pharmacokinetics, Pharmacodynamics, & Metabolism, Medicine Design Pfizer Inc. Groton Connecticut USA

Publisher

Wiley

Subject

General Pharmacology, Toxicology and Pharmaceutics,General Biochemistry, Genetics and Molecular Biology,General Medicine,General Neuroscience

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/cts.12734

Reference48 articles.

1. US Food and Drug Administration (FDA).In Vitro Metabolism‐ and Transporter‐ Mediated Drug‐Drug Interaction Studies Guidance for Industry(2017). .

2. US Food and Drug Administration (FDA).Safety Testing of Drug Metabolites(2016). .

3. European Medicines Agency (EMA).Guideline on the investigation of drug interactions..

4. Prediction of Relative In Vivo Metabolite Exposure from In Vitro Data Using Two Model Drugs: Dextromethorphan and Omeprazole

5. The Use of In Vitro Data and Physiologically-Based Pharmacokinetic Modeling to Predict Drug Metabolite Exposure: Desipramine Exposure in Cytochrome P4502D6 Extensive and Poor Metabolizers Following Administration of Imipramine

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2. Metabolite Bioanalysis in Drug Development: Recommendations from the IQ Consortium Metabolite Bioanalysis Working Group;Clinical Pharmacology & Therapeutics;2023-12-10

3. Physiologically Based Pharmacokinetic Modeling for Quantitative Prediction of Exposure to a Human Disproportionate Metabolite of the Selective Na_V1.7 Inhibitor DS-1971a, a Mixed Substrate of Cytochrome P450 and Aldehyde Oxidase, Using Chimeric Mice With Humanized Liver;Drug Metabolism and Disposition;2022-10-23

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