A Decade in the MIST: Learnings from Investigations of Drug Metabolites in Drug Development under the “Metabolites in Safety Testing” Regulatory Guidance-Reference-Cited by-同舟云学术

A Decade in the MIST: Learnings from Investigations of Drug Metabolites in Drug Development under the “Metabolites in Safety Testing” Regulatory Guidance

Published:2018-02-27 Issue:6 Volume:46 Page:865-878
ISSN:0090-9556
Container-title:Drug Metabolism and Disposition
language:en
Short-container-title:Drug Metab Dispos

Author:

Schadt Simone,Bister Bojan,Chowdhury Swapan K.,Funk Christoph,Hop Cornelis E. C. A.,Humphreys W. Griffith,Igarashi Fumihiko,James Alexander D.,Kagan Mark,Khojasteh S. Cyrus,Nedderman Angus N. R.,Prakash Chandra,Runge Frank,Scheible Holger,Spracklin Douglas K.,Swart Piet,Tse Susanna,Yuan Josh,Obach R. Scott

Publisher

American Society for Pharmacology & Experimental Therapeutics (ASPET)

Subject

Pharmaceutical Science,Pharmacology

Reference76 articles.

1. Interpretation and Considerations on the Safety Evaluation of Human Drug Metabolites

2. Approaches to the Assessment of Stable and Chemically Reactive Drug Metabolites in Early Clinical Trials

3. Drug Metabolites in Safety Testing

4. Directed evolution of cytochrome P450 enzymes for biocatalysis: exploiting the catalytic versatility of enzymes with relaxed substrate specificity

5. Influence of CYP2C19 genotype on the pharmacokinetics of R483, a CYP2C19 substrate, in healthy subjects and type 2 diabetes patients

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