Overall impact of the regulatory requirements for genotoxic impurities on the drug development process

European Journal of Pharmaceutical Sciences

Volumn 43, Issue 1-2, 2011, Pages 1-15

  Giordani, Antonio ^a   Kobel, Werner ^b   Gally, Hans Ulrich ^c  

^a Rotta Research Laboratorium   (Italy)

^b ToxAdvice GmbH   (Switzerland)

^c GxP GmbH   (Switzerland)

Author keywords

Analytical control strategy; Genotoxic impurities; GTI analysis; GTI toxicological assessment; ICH guidelines; Quality by design

Indexed keywords

CARCINOGEN; CHEMICAL COMPOUND; DNA;

ALGORITHM; AMES TEST; CHROMOSOME ABERRATION; CHROMOSOME ANALYSIS; CHROMOSOME DAMAGE; COMPUTER PROGRAM; DATA BASE; DRUG CARCINOGENICITY; DRUG DEVELOPMENT; DRUG IMPURITY; DRUG MANUFACTURE; DRUG MARKETING; DRUG SELECTIVITY; DRUG STRUCTURE; FOOD AND DRUG ADMINISTRATION; GENE MUTATION; GENOTOXIC IMPURITY; HUMAN; MUTAGEN TESTING; NONHUMAN; PREVENTION; PRIORITY JOURNAL; QUALITY CONTROL; REVIEW; SENSITIVITY ANALYSIS;

ANIMALS; CHEMISTRY, PHARMACEUTICAL; DNA DAMAGE; DRUG CONTAMINATION; DRUG INDUSTRY; EUROPE; GUIDELINES AS TOPIC; HUMANS; INTERNATIONAL COOPERATION; MICE; MUTAGENS; PHARMACEUTICAL PREPARATIONS; QUALITY CONTROL; RISK ASSESSMENT; TOXICITY TESTS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 79955701013     PISSN: 09280987     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejps.2011.03.004     Document Type: Review

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123. ICH Q3C (R4): Impurities: Residual Solvents, CPMP/ICH/283/99, February 2009.
124. Guideline on the Limits of Genotoxic Impurities, CPMP/SWP/5199/02, EMEA/CHMP/QWP/251344/2006.
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127. EDQM, European Directorate for the Quality of Medicines & HealthCare, European Pharmacopoeia Commission, Group Com, Potentially Genotoxic Impurities, Monograph No. 2034, March 2008. http://www.edqm.eu/medias/fichiers/NEW-Policy- Paper-Potentially-genotoxic-impurities-March-2008.pdf.
128. ICH S2 (R1) guideline: Guidance on genotoxicity testing and data interpretation for pharmaceuticals intended for human use, EMEA/CHMP/ICH/126642/ 2008.
129. Risk assessment methodologies and approaches for genotoxic and carcinogenic substances; Scientific Committee on Health and Environmental Risks (SCHER), Scientific Committees, January 21st, 2009. http://ec.europa.eu/health/ phrisk/risk.
130. Guidance for Industry and Review Staff. Recommended Approaches to Integration of Genetic Toxicology Study Results, Center for Drug Evaluation and Research, January 2006.
131. ICH S9, Nonclinical Evaluation for Anticancer Pharmaceuticals, March 2009.
132. ICH Q8 (R2): Pharmaceutical Development, August 2009.
133. ICH Q9: Quality Risk Management, January 2006.
134. ICH Q10: Pharmaceutical Quality System, June 2008.
135. Quality Implementation Working Group on Q8, Q9 and Q10, Question & Answers, October 2009.