Development of the Methodology for <i>in Silico</i> Reactivity-Based Purge Predictions: Making Mirabilis Think Like a Chemist-Reference-Cited by-同舟云学术

Development of the Methodology for in Silico Reactivity-Based Purge Predictions: Making Mirabilis Think Like a Chemist

Published:2023-03-29 Issue:10 Volume:27 Page:1773-1783
ISSN:1083-6160
Container-title:Organic Process Research & Development
language:en
Short-container-title:Org. Process Res. Dev.

Author:

McManus James A.¹^ORCID,Lopez-Rodríguez Rocío¹,Murphy Natasha S.¹,James Lara¹,O’Connor Daniel C.¹,Gavins Georgina C.¹,Burns Michael J.¹^ORCID

Affiliation:

1. Lhasa Limited, Leeds LS11 5PS, West Yorkshire, U.K.

Publisher

American Chemical Society (ACS)

Subject

Organic Chemistry,Physical and Theoretical Chemistry

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.oprd.3c00003

Reference15 articles.

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3. ICH. ICH Guideline M7 - Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk. Guideline 2014. https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-m7r1-assessment-control-dna-reactive-mutagenic-impurities-pharmaceuticals-limit_en.pdf.

4. Establishing best practise in the application of expert review of mutagenicity under ICH M7

5. ICH. ICH guideline M7 - Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk Questions and Answers. https://www.ich.org/page/multidisciplinary-guidelines#7-2.

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