Risk Assessment of Genotoxic Impurities in New Chemical Entities: Strategies To Demonstrate Control-Reference-Cited by-同舟云学术

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

Author:

Teasdale Andrew¹,Elder David²,Chang Sou-Jen³,Wang Sophie⁴,Thompson Richard⁵,Benz Nancy⁶,Sanchez Flores Ignacio H.⁷

Affiliation:

1. AstraZeneca, Charter Way, Silk Road Business Park, Macclesfield, Cheshire SK10 2NX, United Kingdom

2. GlaxoSmithKline, Park Road, Ware, Hertfordshire SG12 0DP, United Kingdom

3. Abbott Laboratories, 200 Abbott Park Road, PA71, Building AP-50, Abbott Park, Illinois 60064-6220, United States

4. Amgen Inc., 1 Amgen Center Drive, Thousand Oaks, California 91320, United States

5. Ben Venue Laboratories Inc., Boehringer Ingelheim, 300 Northfield Road, Bedford, Ohio 44146, United States

6. Abbott Laboratories Department R45T, Building R8-2, 1401 Sheridan Road, North Chicago, Illinois 60064, United States

7. Takeda Global Research & Development Center, Inc., One Takeda Parkway, Deerfield, Illinois 60015, United States

Publisher

American Chemical Society (ACS)

Subject

Organic Chemistry,Physical and Theoretical Chemistry

Link

Reference25 articles.

1. International Conference on Harmonisation (ICH). Guideline Q3A (R2): Impurities in New Drug Substances; October 2006.

2. International Conference on Harmonisation (ICH). Guideline Q3B (R2): Impurities in New Drug Products; 2006.

3. International Conference on Harmonisation (ICH), Guideline Q3C (R4): Impurities: Guidelines for Residual Solvents; 2009.

4. EMEA/CHMP, Guideline on the Limits of Genotoxic Impurities,CPMP/SWP/5199/02; 2006

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