Leveraging ICH M7 Control Options 3 and 4: Discussion and Clarification Using Industrial Case Studies-Reference-Cited by-同舟云学术

Leveraging ICH M7 Control Options 3 and 4: Discussion and Clarification Using Industrial Case Studies

Published:2024-07-23 Issue:8 Volume:28 Page:3295-3306
ISSN:1083-6160
Container-title:Organic Process Research & Development
language:en
Short-container-title:Org. Process Res. Dev.

Author:

Urquhart Michael W.¹^ORCID,Burns Michael J.²^ORCID,Clark Hugh F.¹,Crochard Jean-Philippe³,Dirat Olivier⁴^ORCID,Hildbrand Stefan³,Moessner Christian³,Pascoe David D.¹,Roberts Alastair J.¹,Teasdale Andrew⁵^ORCID,Thiel Oliver R.⁶^ORCID

Affiliation:

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

2. Lhasa Limited, Leeds LS1 5PS, West Yorkshire, U.K.

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

4. Pfizer Global Regulatory Sciences, Sandwich CT13 9NJ, U.K.

5. AstraZeneca, Macclesfield, Cheshire SK10 2NA, U.K.

6. Amgen Incorporated, Cambridge, Massachusetts 02142, United States

Publisher

American Chemical Society (ACS)

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.oprd.4c00207

Reference16 articles.

1. ICH. Impurities in new drug substances Q3A(R2). Guideline. https://database.ich.org/sites/default/files/Q3A%28R2%29%20Guideline.pdf (accessed Sept 29, 2023).

2. ICH. Impurities in new drug products Q3B(R2). Guideline. https://database.ich.org/sites/default/files/Q3B%28R2%29%20Guideline.pdf (accessed Sept 29, 2023).

3. Is Avoidance of Genotoxic Intermediates/Impurities Tenable for Complex, Multistep Syntheses?

4. ICH. Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk M7(R2). Guideline. https://database.ich.org/sites/default/files/ICH_M7%28R2%29_Guideline_Step4_2023_0216_0.pdf (accessed Sept 29, 2023).

5. Control of Mutagenic Impurities: Survey of Pharmaceutical Company Practices and a Proposed Framework for Industry Alignment