Toward regulatory acceptance and improving the prediction confidence of in silico approaches: a case study of genotoxicity-Reference-Cited by-同舟云学术

Toward regulatory acceptance and improving the prediction confidence of in silico approaches: a case study of genotoxicity

Published:2021-06-21 Issue:8 Volume:17 Page:987-1005
ISSN:1742-5255
Container-title:Expert Opinion on Drug Metabolism & Toxicology
language:en
Short-container-title:Expert Opinion on Drug Metabolism & Toxicology

Author:

Tcheremenskaia Olga¹,Benigni Romualdo²

Affiliation:

1. Environmental and Health Department, Istituto Superiore Di Sanità (ISS), Rome, Italy, Rome, Italy

2. Alpha‐Pretox (www.alpha‐pretox.com), Rome, Italy

Publisher

Informa UK Limited

Subject

Pharmacology,Toxicology,General Medicine

Link

https://www.tandfonline.com/doi/pdf/10.1080/17425255.2021.1938540

Reference112 articles.

1. European Medicines Agency. ICH guideline S2 (R1) on genotoxicity testing and data interpretation for pharmaceuticals intended for human use. 2012. EMA/CHMP/ICH/126642/200.

2. European Commission. Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC. The Official Journal of the European Union. L396/1. 2006.

3. European Medicines Agency. ICH guideline M7(R1) on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk. 2017. EMA/CHMP/ICH/83812/2013

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