Regulatory Highlights

Author:

Teasdale Andrew1

Affiliation:

1. AstraZeneca, Macclesfield SK10 2NA, United Kingdom

Publisher

American Chemical Society (ACS)

Subject

Organic Chemistry,Physical and Theoretical Chemistry

Reference16 articles.

1. Regulatory Highlights

2. ICH M7 Step 4 June 2014, Assessment and Control of DNA Reactive (Mutagenic) Impurities In Pharmaceuticals To Limit Potential Carcinogenic Risk.http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Multidisciplinary/M7/M7_Step_4.pdf.

3. Guidance for Industry - Q3A (R2) Impurities in New Drug Substances, 25 October 2006.http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3A_R2/Step4/Q3A_R2__Guideline.pdf.

4. ICH S9 Nonclinical Evaluation For Anticancer Pharmaceuticals.http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Safety/S9/Step4/S9_Step4_Guideline.pdf.

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

Cited by 2 articles. 订阅此论文施引文献 订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献

1. Scientific, statistical, practical, and regulatory considerations in design space development;Drug Development and Industrial Pharmacy;2017-12-19

2. Regulatory Highlights;Organic Process Research & Development;2015-10-14

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