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Post-approval safety data management : definitions and standards for expedited reporting.

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Format:
Book
Conference/Event
Government document
Contributor:
United States. Food and Drug Administration
Conference Name:
International Conference on Harmonisation http://viaf.org/viaf/130234339
Language:
English
Subjects (All):
Drugs--Side effects--Reporting.
Drugs.
Clinical pharmacology.
Pharmacovigilance.
Drug monitoring.
Physical Description:
1 online resource (12)
Other Title:
Definitions and standards for expedited reporting
Place of Publication:
[Rockville, Md.?] : [U.S. Dept. of Health and Human Services, Food and Drug Administration], [2003]
Notes:
Title from PDF title page (viewed on June 19, 2009).
"ICH harmonised tripartite guideline draft."
"Recommended for adoption at step 2 of the ICH process on July 19, 2003 by the ICH Steering Committee."
"ICH E2E ver. 3.8."
OCLC:
404100715

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