A decade of drug metabolite safety testing: industry and regulatory shared learning

EXPERT OPINION ON DRUG METABOLISM & TOXICOLOGY

卷 13, 期 9, 页码 897-900

TAYLOR & FRANCIS LTD

Disproportionate human metabolites; FDA guidance; metabolite safety testing; safety coverage

Biochemistry & Molecular Biology Pharmacology & Pharmacy Toxicology

1. Eli Lilly Co.
2. U.S. Food and Drug Administration