Special endpoint and product specific considerations in pharmaceutical acceptable daily exposure derivation. [electronic resource]
- Regulatory toxicology and pharmacology : RTP Aug 2016
- S79-93 p. digital
Publication Type: Journal Article; Review
1096-0295
10.1016/j.yrtph.2016.05.022 doi
Animals Dose-Response Relationship, Drug Drug Contamination--prevention & control Drug Hypersensitivity--immunology Drug Industry--legislation & jurisprudence Drug-Related Side Effects and Adverse Reactions--immunology Guidelines as Topic Health Policy Humans Mutagenicity Tests No-Observed-Adverse-Effect Level Occupational Exposure--adverse effects Occupational Health--legislation & jurisprudence Pharmaceutical Preparations--classification Pharmacokinetics Policy Making Proteins--adverse effects Risk Assessment Toxicity Tests--methods Toxicokinetics