The EMEA guideline on first-in-human clinical trials and its impact on pharmaceutical development.
Milton
Mark N
MN
Tempo Pharmaceuticals, Cambridge, Massachusetts 02142, USA. mnmilt@gmail.com
Horvath
Christopher J
CJ
D000818:Animals; D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards; D015331:Cohort Studies; D017277:Drug Approval / Q000331:legislation & jurisprudence / Q000458:organization & administration; D004353:Drug Evaluation, Preclinical / Q000009:adverse effects*; D004345:Drug Industry / Q000331:legislation & jurisprudence / Q000458:organization & administration; D064420:Drug-Related Side Effects and Adverse Reactions; D005060:Europe; D006077:Government Agencies / Q000331:legislation & jurisprudence / Q000458:organization & administration; D017408:Guidelines as Topic; D006801:Humans; D010599:Pharmacokinetics; D010600:Pharmacology / Q000379:methods; D014481:United States; D014486:United States Food and Drug Administration