Management of organic impurities in small molecule medicinal products: Deriving safe limits for use in early development.
Harvey, James
Management of organic impurities in small molecule medicinal products: Deriving safe limits for use in early development. [electronic resource] - Regulatory toxicology and pharmacology : RTP Mar 2017 - 116-123 p. digital
Publication Type: Journal Article; Review
1096-0295
10.1016/j.yrtph.2016.12.011 doi
Animals
Clinical Trials as Topic--legislation & jurisprudence
Dose-Response Relationship, Drug
Drug Contamination
Drug Discovery--legislation & jurisprudence
Drug and Narcotic Control
Government Regulation
Health Policy
Humans
No-Observed-Adverse-Effect Level
Organic Chemicals--adverse effects
Patient Safety--legislation & jurisprudence
Pharmaceutical Preparations--analysis
Policy Making
Quality Control
Risk Assessment
Risk Factors
Threshold Limit Values
Time Factors
Toxicity Tests--methods
Management of organic impurities in small molecule medicinal products: Deriving safe limits for use in early development. [electronic resource] - Regulatory toxicology and pharmacology : RTP Mar 2017 - 116-123 p. digital
Publication Type: Journal Article; Review
1096-0295
10.1016/j.yrtph.2016.12.011 doi
Animals
Clinical Trials as Topic--legislation & jurisprudence
Dose-Response Relationship, Drug
Drug Contamination
Drug Discovery--legislation & jurisprudence
Drug and Narcotic Control
Government Regulation
Health Policy
Humans
No-Observed-Adverse-Effect Level
Organic Chemicals--adverse effects
Patient Safety--legislation & jurisprudence
Pharmaceutical Preparations--analysis
Policy Making
Quality Control
Risk Assessment
Risk Factors
Threshold Limit Values
Time Factors
Toxicity Tests--methods