Risk Assessment of Genotoxic Impurities in Marketed Compounds Administered over a Short-Term Duration: Applications to Oncology Products and Implications for Impurity Control Limits-Reference-Cited by-同舟云学术

Risk Assessment of Genotoxic Impurities in Marketed Compounds Administered over a Short-Term Duration: Applications to Oncology Products and Implications for Impurity Control Limits

Published:2010-06-07 Issue:4 Volume:14 Page:986-992
ISSN:1083-6160
Container-title:Organic Process Research & Development
language:en
Short-container-title:Org. Process Res. Dev.

Author:

Callis Courtney M.¹,Bercu Joel P.¹,DeVries Keith M.¹,Dow Linda K.¹,Robbins David K.¹,Varie David L.¹

Affiliation:

1. Health, Safety, & Environmental, Analytical Sciences Research & Development, and Chemical Product Research & Development, Lilly Research Laboratories, Eli Lilly & Company, Indianapolis, Indiana 46285, U.S.A.

Publisher

American Chemical Society (ACS)

Subject

Organic Chemistry,Physical and Theoretical Chemistry

Link

https://pubs.acs.org/doi/pdf/10.1021/op1000226

Reference16 articles.

1. ICH Harmonized Tripartite Guideline: Impurities in New Drug Substances (Q3A),(R2);International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), 2006.

2. Approaches to Assessment, Testing Decisions, and Analytical Determination of Genotoxic Impurities in Drug Substances

3. A rationale for determining, testing, and controlling specific impurities in pharmaceuticals that possess potential for genotoxicity

4. Guideline on the Limits of Genotoxic Impurities,CPMP/SWP/5199/02, EMEA/CHMP/QWP/251344/2006;Committee for Medicinal Products (CHMP), European Medicines Agency (EMEA):London, 28 June 2006

5. Analytical control of genotoxic impurities in the pazopanib hydrochloride manufacturing process

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