New Semi-Automated Computer-Based System for Assessing the Purge of Mutagenic Impurities-Reference-Cited by-同舟云学术

New Semi-Automated Computer-Based System for Assessing the Purge of Mutagenic Impurities

Published:2019-10-04 Issue:11 Volume:23 Page:2470-2481
ISSN:1083-6160
Container-title:Organic Process Research & Development
language:en
Short-container-title:Org. Process Res. Dev.

Author:

Burns Michael J.¹^ORCID,Ott Martin A.¹,Teasdale Andrew²,Stalford Susanne A.¹,Antonucci Vincent³,Baumann Jens-Christoph⁴,Brown Roland⁵,Covey-Crump Elizabeth M.¹,Elder David⁶,Elliott Eric⁷,Fennell Jared W.⁸,Gallou Fabrice⁹,Ide Nathan D.¹⁰,Itoh Tetsuji³,Jordine Guido⁹,Kallemeyn Jeffrey M.¹⁰,Lauwers Dirk¹¹,Looker Adam R.¹²^ORCID,Lovelle Lucie E.⁹^ORCID,Molzahn Robert¹³,Schils Didier¹⁴,Schulte Oestrich Rolf⁴,Sluggett Gregory W.¹⁵,Stevenson Neil¹⁶,Talavera Pere¹⁷,Urquhart Michael W.¹⁶^ORCID,Varie David L.⁸,Welch Dennie S.¹⁰

Affiliation:

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

2. AstraZeneca, Macclesfield SK10 4TG, Cheshire, U.K.

3. Merck Sharp & Dohme Corporation, Rahway, New Jersey 07033, United States

4. F. Hoffmann-La Roche Limited, Basel CH-4070, Switzerland

5. Pfizer, Sandwich CT13 9ND, Kent, U.K.

6. Consultant, Hertford SG14 2DE, Hertfordshire, U.K.

7. Takeda Pharmaceuticals, Cambridge, Massachusetts 02139, United States

8. Eli Lilly and Company, Indianapolis, Indiana 46285, United States

9. Novartis, Basel CH-4056, Switzerland

10. AbbVie, North Chicago, Illinois 60064, United States

11. Janssen Pharmaceutica NV, Beerse 2340, Belgium

12. Vertex Pharmaceuticals, Boston, Massachusetts 02210, United States

13. Excella GmbH & Company KG, Feucht 90537, Germany

14. Galapagos NV, Mechelen B-2800, Belgium

15. Pfizer, Groton 06340, Connecticut, United States

16. GlaxoSmithKline, Stevenage SG1 2NY, Hertfordshire, U.K.

17. Esteve Química, Barcelona 08030, Spain

Publisher

American Chemical Society (ACS)

Subject

Organic Chemistry,Physical and Theoretical Chemistry

Link

http://pubs.acs.org/doi/pdf/10.1021/acs.oprd.9b00358

Reference41 articles.

1. Genotoxic Impurities

2. A Tool for the Semiquantitative Assessment of Potentially Genotoxic Impurity (PGI) Carryover into API Using Physicochemical Parameters and Process Conditions

3. Risk Assessment of Genotoxic Impurities in New Chemical Entities: Strategies To Demonstrate Control

4. ICH. ICH Guideline M7—Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk. Guideline, 2014. https://doi.org/http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Multidisciplinary/M7/M7_R1_Addendum_Step_4_31Mar2017.pdf.

5. Assessment of Predictivity of Semiquantitative Risk Assessment Tool: Pazopanib Hydrochloride Genotoxic Impurities

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