FDA Guidance for Industry Exposure-Response Relationships — Study Design, Data Analysis, and Regulatory Applications

Titel:
FDA Guidance for Industry Exposure-Response Relationships — Study Design, Data Analysis, and Regulatory Applications
Herkunft/Verlag:

Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/ , http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072109.pdf

Dokumentenart:
Guidance for Industry
Inhalt:
Informationen zur Datenübermittlung von Informationen über Expositionsreaktionen bei der Entwicklung von Arzneimitteln inkl. Biologika

Zurück

GMP Seminare nach Thema