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M7(R1) assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk

Series Title(s):
Guidance for industry
Contributor(s):
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Biologics Evaluation and Research (U.S.), issuing body.
Center for Drug Evaluation and Research (U.S.), issuing body.
Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, March 2018
Language(s):
English
Format:
Text
Subject(s):
Carcinogenicity Tests -- standards
Carcinogens
Chemistry, Pharmaceutical
DNA Damage -- genetics
Drug Contamination -- prevention & control
Mutagenicity Tests -- standards
Mutagens
Acrylonitrile -- toxicity
Aniline Compounds -- toxicity
Benzyl Compounds -- toxicity
Bis(Chloromethyl) Ether -- toxicity
Ethyl Chloride -- toxicity
Hydrazines -- toxicity
Hydrogen Peroxide -- toxicity
Methyl Chloride -- toxicity
Nitrobenzenes -- toxicity
No-Observed-Adverse-Effect Level
Quality Control
Toxicity Tests -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
Genre(s):
Guideline
Technical Report
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (129 pages))
Edition:
Revision 1
Illustrations:
Illustrations
NLM Unique ID:
101734078 (See catalog record)
Series Title(s):
Guidance for industry
Contributor(s):
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Biologics Evaluation and Research (U.S.), issuing body.
Center for Drug Evaluation and Research (U.S.), issuing body.
Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, March 2018
Language(s):
English
Format:
Text
Subject(s):
Carcinogenicity Tests -- standards
Carcinogens
Chemistry, Pharmaceutical
DNA Damage -- genetics
Drug Contamination -- prevention & control
Mutagenicity Tests -- standards
Mutagens
Acrylonitrile -- toxicity
Aniline Compounds -- toxicity
Benzyl Compounds -- toxicity
Bis(Chloromethyl) Ether -- toxicity
Ethyl Chloride -- toxicity
Hydrazines -- toxicity
Hydrogen Peroxide -- toxicity
Methyl Chloride -- toxicity
Nitrobenzenes -- toxicity
No-Observed-Adverse-Effect Level
Quality Control
Toxicity Tests -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
Genre(s):
Guideline
Technical Report
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (129 pages))
Edition:
Revision 1
Illustrations:
Illustrations
NLM Unique ID:
101734078 (See catalog record)