Metabolite Bioanalysis in Drug Development: Recommendations from the IQ Consortium Metabolite Bioanalysis Working Group-Reference-Cited by-同舟云学术

Metabolite Bioanalysis in Drug Development: Recommendations from the IQ Consortium Metabolite Bioanalysis Working Group

Published:2023-12-10 Issue: Volume: Page:
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin Pharma and Therapeutics

Author:

Li Wenkui¹^ORCID,Vazvaei‐Smith Faye²,Dear Gordon³,Boer Jason⁴,Cuyckens Filip⁵^ORCID,Fraier Daniela⁶,Liang Yuexia²,Lu Ding⁷,Mangus Heidi⁸⁹,Moliner Patricia¹⁰,Pedersen Mette Lund¹¹,Romeo Andrea A.⁶^ORCID,Spracklin Douglas K.¹²,Wagner David S.¹³,Winter Serge¹⁴,Xu Xiaohui (Sophia)¹⁵

Affiliation:

1. Pharmacokinetic Sciences, Novartis Biomedical Research East Hanover NJ 07936 USA

2. Pharmacokinetics, Dynamics, Metabolism and Bioanalytics, Merck & Co., Inc. West Point PA 19486 USA

3. Drug Metabolism and Pharmacokinetics, GSK, Ware UK

4. Drug Metabolism and Pharmacokinetics, Incyte Corporation Wilmington DE 19803 USA

5. Drug Metabolism and Pharmacokinetics, Janssen R & D Beerse Belgium

6. Pharmaceutical Sciences, F. Hoffmann‐La Roche Ltd Basel Switzerland

7. Drug Metabolism and Pharmacokinetics, Vertex Pharmaceuticals Inc. Boston MA 02210 USA

8. Drug Metabolism and Pharmacokinetics, Agios Pharmaceuticals Inc., 88 Sidney Street Cambridge MA 02139 USA

9. Current affiliation: Nonclinical Development, Disc Medicine Watertown MA 02472 USA

10. Enzymology and Metabolism, Department of Translational Medicine and Early Development, Sanofi Montpellier Occitanie France

11. DMPK, Research and Early Development, CVRM, BioPharmaceuticals R&D, AstraZeneca Gothenburg Sweden

12. Pharmacokinetics, Dynamics and Metabolism, Pfizer Inc. Groton CT 06340 USA

13. Drug Metabolism and Disposition, AbbVie North Chicago IL 60064 USA

14. Pharmacokinetic Sciences, Novartis Biomedical Research Basel Switzerland

15. Clinical Bioanalysis, Translation Medicine, Daiichi Sankyo, Inc., Basking Ridge NJ 07920 USA

Abstract

The intent of this perspective is to share the recommendations of the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ Consortium) Metabolite Bioanalysis Working Group (WG) on the fit‐for‐purpose metabolite bioanalysis in support of drug development and registration. This report summarizes the considerations for the trigger, timing, and rigor of bioanalysis in the various assessments to address unique challenges due to metabolites, with respect to efficacy and safety, which may arise during drug development from IND enabling studies, and Phase I, Phase II, and Phase III clinical trials to regulatory submission. The recommended approaches ensure that important drug metabolites are identified in a timely manner and properly characterized for efficient drug development.

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://ascpt.onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.3144

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