Do Inhibitory Metabolites Impact DDI Risk Assessment? Analysis of in vitro and in vivo Data from NDA Reviews Between 2013 and 2018-Reference-Cited by-同舟云学术

Do Inhibitory Metabolites Impact DDI Risk Assessment? Analysis of in vitro and in vivo Data from NDA Reviews Between 2013 and 2018

Published:2021-05-08 Issue:2 Volume:110 Page:452-463
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Steinbronn Claire¹,Yang Xinning²,Yu Jingjing¹³,Dimova Hristina⁴,Huang Shiew‐Mei²,Ragueneau‐Majlessi Isabelle¹³,Isoherranen Nina¹

Affiliation:

1. Department of Pharmaceutics University of Washington Seattle Washington USA

2. Office of Clinical Pharmacology Office of Translational Sciences Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

3. UW Drug Interaction Solutions University of Washington Seattle Washington USA

4. Center for Tobacco Products US Food and Drug Administration Silver Spring Maryland USA

Funder

National Institutes of Health

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.2259

Reference34 articles.

1. Hospital admissions/visits associated with drug-drug interactions: a systematic review and meta-analysis

2. In vitro cytochrome P450 inhibition data and the prediction of drug-drug interactions: Qualitative relationships, quantitative predictions, and the rank-order approach

3. Prediction of in vivo drug-drug interactions from in vitro data: impact of incorporating parallel pathways of drug elimination and inhibitor absorption rate constant

4. IMPACT OF PARALLEL PATHWAYS OF DRUG ELIMINATION AND MULTIPLE CYTOCHROME P450 INVOLVEMENT ON DRUG-DRUG INTERACTIONS: CYP2D6 PARADIGM

5. Evaluation of Various Static In Vitro–In Vivo Extrapolation Models for Risk Assessment of the CYP3A Inhibition Potential of an Investigational Drug

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