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Volumn 14, Issue 4, 2010, Pages 1037-1045

Is there a real case for cumulative control of structurally related genotoxic impurities?

Author keywords

[No Author keywords available]

Indexed keywords

ANALYTICAL CHALLENGE; CANCER RISK; END-PRODUCTS; ETHYL CHLORIDE; GENOTOXIC; GENOTOXIC IMPURITIES; LIMITED DATA; MODELLING STUDIES; QUALITY BY DESIGNS; TUMOURS;

EID: 77955366055     PISSN: 10836160     EISSN: 1520586X     Source Type: Journal    
DOI: 10.1021/op900343g     Document Type: Article
Times cited : (6)

References (49)
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    • Guidance for Industry. Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). December 2008.
    • Guidance for Industry. Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). December 2008.
  • 2
    • 77955362324 scopus 로고    scopus 로고
    • Guideline on the Limits of Genotoxic Impurities, Committee for Medicinal Products (CHMP), European Medicines Agency, London. 28 June 2006. (CPMP/SWP/5199/02, EMEA/CHMP/QWP/251344/2006).
    • Guideline on the Limits of Genotoxic Impurities, Committee for Medicinal Products (CHMP), European Medicines Agency, London. 28 June 2006. (CPMP/SWP/5199/02, EMEA/CHMP/QWP/251344/2006).
  • 3
    • 77955344517 scopus 로고    scopus 로고
    • EMEA. Question and Answers on the CHMP Guideline on Genotoxic Impurities. Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency, London. 9 January 2008, CHMP/SWP/431994/2007.
    • EMEA. Question and Answers on the CHMP Guideline on Genotoxic Impurities. Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency, London. 9 January 2008, CHMP/SWP/431994/2007.
  • 9
    • 0000493162 scopus 로고
    • 36595
    • Federal Register 1995, 60 (136), 36582- 36595
    • (1995) Federal Register , vol.60 , Issue.136 , pp. 36582
  • 24
    • 77955375742 scopus 로고    scopus 로고
    • Mutagenicity Test Data of Existing Chemical Substances Based on the Toxicity Investigation of the Industrial Safety and Health Law [Suppl]; Japan Chemical Industry Ecology-Toxicology and Information Center (JETOC): Tokyo, Japan, 1997 and 2000.
    • Mutagenicity Test Data of Existing Chemical Substances Based on the Toxicity Investigation of the Industrial Safety and Health Law [Suppl]; Japan Chemical Industry Ecology-Toxicology and Information Center (JETOC): Tokyo, Japan, 1997 and 2000.
  • 28
    • 77955351926 scopus 로고    scopus 로고
    • Press Release: European Medicines Agency Agrees on Action Plan Following the Recall of Viracept and Recommends Suspension of the Marketing Authorization, London, 2007. EMEA/275367/2007.
    • Press Release: European Medicines Agency Agrees on Action Plan Following the Recall of Viracept and Recommends Suspension of the Marketing Authorization, London, 2007. EMEA/275367/2007.
  • 32
    • 77955355359 scopus 로고    scopus 로고
    • http://ntp.niehs.nih.gov/ntp/htdocs/LT-rpts/tr200.pdf.
  • 33
    • 77955356452 scopus 로고    scopus 로고
    • ICH Expert Working Group. Impurities in New Drug Substances. ICH Q3A(R2).
    • ICH Expert Working Group. Impurities in New Drug Substances. ICH Q3A(R2), 2006.
    • (2006)
  • 37
    • 77955410724 scopus 로고    scopus 로고
    • ICH Expert Working Group. Non-Clinical Evaluation for AntiCancer Pharmaceuticals, Step 3. ICH S9. EMEA/CHMP/ICH/646107/2008, December
    • ICH Expert Working Group. Non-Clinical Evaluation for AntiCancer Pharmaceuticals, Step 3. ICH S9. EMEA/CHMP/ICH/646107/2008, December 2008
    • (2008)
  • 38
    • 77955399539 scopus 로고    scopus 로고
    • ICH Expert Working Group. Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use, ICH S2 (R1).
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  • 43
    • 77955403800 scopus 로고    scopus 로고
    • Amlodipine Besylate monograph, Ph.Eur. monograph 1491
    • 6th ed. (as amended by Supplements 6.1 and 6.2, Council of Europe, Strasbourg).
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    • (2009) European Pharmacopoeia
  • 47
    • 77955354628 scopus 로고    scopus 로고
    • Some data are available in the preceeding reference to assess relative chemical reactivity, in particular, the Swain-Scott s constants, which assess the sensitivity of an electrophilic substrate to nucleophilic attack. The sulfonate esters (MMS, EMS, and IMS) have very different s values: MMS (0.83) > EMS (0.67) > IMS (0.29).
    • Some data are available in the preceeding reference to assess relative chemical reactivity, in particular, the Swain-Scott s constants, which assess the sensitivity of an electrophilic substrate to nucleophilic attack. The sulfonate esters (MMS, EMS, and IMS) have very different s values: MMS (0.83) > EMS (0.67) > IMS (0.29).


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