Development Safety Update Report Dsur, Harmonizing the Format and Content for Periodic Safety During Clinical Trials: Report of CIOMS Working Group VII - Brossura

Council For International Organizations Of Medical Sciences

Brossura

ISBN 10: 9290360801 ISBN 13: 9789290360803

Casa editrice: World Health Organization, 2006

Riassunto

This report presents the work of the Council for International Organizations of Medical Science's working group on the "Development Safety Update Report: Harmonizing the Format and Content for Periodic Safety Reporting During Clinical Trials," which involved the participation of senior scientists from drug regulatory authorities and pharmaceutical companies in proposing and drafting an internationally harmonized pre-approval document that would summarize the safety experience and explain actions proposed or taken for a pharmaceutical clinical trial or for an entire pharmaceutical development program. The proposed document is modeled after, and intended to align with, the post-approval "Periodic Safety Update Report" for marketed products. Annotation ©2007 Book News, Inc., Portland, OR (booknews.com)

Dettagli dell'edizione

• Editore: World Health Organization
• Data di pubblicazione: 2006
• Lingua: Inglese
• ISBN 10: 9290360801
• ISBN 13: 9789290360803
• Rilegatura: Copertina flessibile
• Numero edizione: 1
• Numero di pagine: 203
• Contatto del produttore: non disponibile
• Persona responsabile: non disponibile