Gould, Janet

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