Management of organic impurities in small molecule medicinal products: Deriving safe limits for use in early development. [electronic resource]
Producer: 20170313Description: 116-123 p. digitalISSN:- 1096-0295
- 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
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Publication Type: Journal Article; Review
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