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The development safety update report (DSUR): harmonizing the format and content for periodic safety reporting during clinical trials: report of CIOMS Working Group VII - Softcover
Synopsis
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)
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Synopsis
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
"About this title" may belong to another edition of this title.
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Development Safety Update Report (DSUR) Harmonizing the Format and Content for Periodic Safety Report during Clinical Trials: Report of CIOMS Working Group VII (A CIOMS Publication)
Published by
World Health Organization, 2006
ISBN 10: 9290360801
ISBN 13: 9789290360803
Used
Softcover
Seller: Blue Vase Books, Interlochen, MI, U.S.A.
Seller rating 5 out of 5 stars
Condition: good. The item shows wear from consistent use, but it remains in good condition and works perfectly. All pages and cover are intact including the dust cover, if applicable . Spine may show signs of wear. Pages may include limited notes and highlighting. May NOT include discs, access code or other supplemental materials. Seller Inventory # BVV.9290360801.G