Regulatory Highlights-Reference-Cited by-同舟云学术

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Regulatory Highlights

Published:2024-08-20 Issue: Volume: Page:
ISSN:1083-6160
Container-title:Organic Process Research & Development
language:en
Short-container-title:Org. Process Res. Dev.

Author:

Teasdale Andrew¹^ORCID,Gordon Carolyn²

Affiliation:

1. Chemical Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Macclesfield SK10 2NA, United Kingdom

2. CMC Regulatory Affairs, Oncology Regulatory Science & Strategy, R&D, AstraZeneca, Macclesfield SK10 2NA, United Kingdom

Publisher

American Chemical Society (ACS)

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.oprd.4c00341

Reference19 articles.

1. Regulatory Highlights

2. Determining recommended acceptable intake limits for N-nitrosamine impurities in pharmaceuticals: Development and application of the Carcinogenic Potency Categorization Approach (CPCA)

3. Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products; EMA/409815/2020 rev. 21; European Medicines Agency, 2024.

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