Acceptability of low levels of genotoxic impurities in new drug substances: Conclusions of the Drug Information Association (DIA)/European Medicines Agency (EMEA) workshop, October 27-28, 2003 in London, UK

International Journal of Pharmaceutical Medicine

Volumn 18, Issue 4, 2004, Pages 221-223

  Kasper, Peter ^a   Kirkland, David ^b   Leblanc, Bernard ^c   Sjöberg, Per ^d   Spindler, Per ^e  

^a BfArM   (Germany)

^b UK   (United Kingdom)

^c PFIZER INC   (United States)

^d Eureda   (Sweden)

^e BioImage AS   (Denmark)

Author keywords

[No Author keywords available]

Indexed keywords

CARCINOGEN; DRUG; DRUG ADDITIVE;

ADVISORY COMMITTEE; CARCINOGENICITY; COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE; CONFERENCE PAPER; CONSENSUS DEVELOPMENT; DRUG CONTROL; DRUG EXPOSURE; DRUG IMPURITY; DRUG INDUSTRY; DRUG INFORMATION; DRUG INFORMATION AGENCY; DRUG SAFETY; EUROPE; EUROPEAN MEDICINES AGENCY; FOOD SAFETY; GENOTOXICITY; HUMAN; MANDATORY PROGRAM; MAXIMUM ALLOWABLE CONCENTRATION; NONHUMAN; OCCUPATIONAL SAFETY; ORGANIZATION; POLLUTION CONTROL; PRACTICE GUIDELINE; PRIORITY JOURNAL; RISK ASSESSMENT; RISK MANAGEMENT; THRESHOLD OF TOXICOLOGICAL CONCERN; WORKSHOP;

EID: 10844296613     PISSN: 13649027     EISSN: None     Source Type: Journal    
DOI: 10.1097/00124363-200418040-00004     Document Type: Conference Paper

References (10)

1. Committee for Proprietary Medicinal Products (CPMP). Position paper on the limits of genotoxic impurities. CPMP/SWP/5199/02/draft 2. London: CPMP, 2002 Dec 18
2. Kirkland D, Snodin D. Setting limits for genotoxic impurities in new drug substances: threshold-based and pragmatic approaches. Int J Pharm Med 2004; 18 (4): 197-207
3. Kasper P. Assessment and acceptance of thresholds of genotoxic impurities in new drug substances: a regulatory perspective. Int J Pharm Med 2004; 18 (4): 209-14
4. Leblanc B, Charuel C, Ku W, et al. Acceptability of low levels of genotoxic impurities in new drug substances: case reports. Int J Pharm Med 2004; 18 (4): 215-20
5. International Life Sciences Institute. Threshold of toxicological concern for chemical substances present in the diet. Report of a workshop held in October 1999. ILSI Europe Report Series 2000. Brussels: ILSI Europe, 2000
6. Kroes R, Galli C, Munro I, et al. Threshold of toxicological concern for chemical substances present in the diet: a practical tool for assessing the need for toxicity testing. Fd Chem Toxicol 2000; 38: 255-312
7. Kroes R, Kozianowski G. Threshold of toxicological concern (TTC) in food safety assessment. Tox Lett 2002; 127: 43-6
8. The Carcinogenic Potency Database (CPDB) [online]. Available from URL: http://potency.berkeley.edu/cpdb.html [Accessed 2004 Oct 6]
9. Kroes R, Renwick AG, Cheeseman M, et al. Structure-based threshold of toxicological concern (TTC): guidance for application to substances present at low levels in the diet. Fd Chem Toxicol 2004; 42: 65-83
10. Committee for Medicinal Products for Human Use (CHMP). Guideline on the limits of genotoxic impurities. CPMP/SWP/5199/02, London, 23 June 2004 [re-released for consultation; online]. Available from URL: http://www.emea.eu. int/pdfs/human/swp/519902en.pdf [Accessed 2004 Oct 1]