Genotoxicity Assessment of Drug Metabolites in the Context of MIST and Beyond-Reference-Cited by-同舟云学术

Genotoxicity Assessment of Drug Metabolites in the Context of MIST and Beyond

Published:2019-12-20 Issue:1 Volume:33 Page:10-19
ISSN:0893-228X
Container-title:Chemical Research in Toxicology
language:en
Short-container-title:Chem. Res. Toxicol.

Author:

Zeller Andreas¹^ORCID,Brigo Alessandro¹,Brink Andreas¹,Guerard Melanie¹,Lang Dieter²^ORCID,Muster Wolfgang¹,Runge Frank³,Sutter Andreas²,Vock Esther³,Wichard Jörg²,Schadt Simone¹^ORCID

Affiliation:

1. Roche Pharmaceutical Research & Early Development, Pharmaceutical Sciences, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd., Grenzacherstrasse 124, 4070 Basel, Switzerland

2. Bayer AG, Pharmaceuticals, Research Center Aprath, 42096 Wuppertal, Germany

3. Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Strasse 65, 88400 Biberach, Germany

Publisher

American Chemical Society (ACS)

Subject

Toxicology,General Medicine

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.chemrestox.9b00348

Reference48 articles.

1. FDA (2016) Guidance for industry: safety testing of drug metabolites. Center for Drug Evaluation and Research, Food and Drug Administration, U.S. Department of Health and Human Services, Silver Spring, MD.

2. ICH (2010) M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals.

3. ICH (2013) M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals. Questions and Answers (R2).

4. Which Human Metabolites Have We MIST? Retrospective Analysis, Practical Aspects, and Perspectives For Metabolite Identification and Quantification in Pharmaceutical Development

Cited by 11 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Metabolites in the regulatory risk assessment of pesticides in the EU;Frontiers in Toxicology;2023-12-19

2. In vivo genotoxicity testing strategies: Report from the 8th International Workshop on Genotoxicity Testing (IWGT);Environmental and Molecular Mutagenesis;2023-12-15

3. In silico ADME/tox comes of age: twenty years later;Xenobiotica;2023-08-08

4. Development and Validation for Quantification of 7-Nitroso Impurity in Sitagliptin by Ultraperformance Liquid Chromatography with Triple Quadrupole Mass Spectrometry;Molecules;2022-12-05

5. Flavone cirsimarin impairs cell proliferation, migration, and invasion in MCF-7 cells grown in 2D and 3D models;Toxicology in Vitro;2022-09