FDA Guidance for Industry: Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency DRAFT GUIDANCE

Titel:
FDA Guidance for Industry: Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency DRAFT GUIDANCE
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/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm078526.pdf

Dokumentenart:
Guidance for Industry DRAFT
Inhalt:
Leitfaden zu Studien zu Sicherheit, Wirksamkeit und Pharmakokinetik bei der Zulassung von Immunglobulinen als Ersatz bei der Therapie primärer Immundefiziens

Zurück

GMP Seminare nach Thema