Guidance for Industry: Safety Reporting Requirements for INDs (Investigational New Drug Applications) and BA/BE (Bioavailability/Bioequivalence)Studies (PDF-688KB)
open here to see the full-text: 23 pages
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM227351.pdf
No hay comentarios:
Publicar un comentario