The Importance of the Human Mass Balance Study in Regulatory Submissions-Reference-Cited by-同舟云学术

The Importance of the Human Mass Balance Study in Regulatory Submissions

Published:2019-10-25 Issue:11 Volume:8 Page:792-804
ISSN:2163-8306
Container-title:CPT: Pharmacometrics & Systems Pharmacology
language:en
Short-container-title:CPT Pharmacometrics Syst. Pharmacol.

Author:

Coppola Paola¹,Andersson Anita²³,Cole Susan¹

Affiliation:

1. Medicines and Healthcare Products Regulatory Agency London UK

2. European Medicines Agency Amsterdam The Netherlands

3. Medical Products Agency Uppsala Sweden

Publisher

Wiley

Subject

Pharmacology (medical),Modeling and Simulation

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/psp4.12466

Reference18 articles.

1. European Commission.Revision 9. Accessed November 2018.

2. International Council for Harmonisation.M3 (R2) Non‐clinical safety studies for the conduct of human clinical trials for pharmaceuticals. EMA/CPMP/ICH/286/1995 . Accessed December 2009.

3. European Medicines Agency.Drug interaction guideline on the investigation of drug interactions. CPMP/EWP/560/95/Rev. 1 Corr. 2** . Accessed June 2012.

4. Drug Metabolites in Safety Testing

5. US Food and Drug Administration.FDA safety testing of drug metabolites guidance for industry 2008.

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