The Locator -- [(subject = "Adverse Drug Reaction Reporting Systems")]

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Title:
Clinical safety data management : definitions and standards for expedited reporting.
Publisher:
U.S. Department of Health and Human ServicesPublic Health Service, Food and Drug Administration,
Copyright Date:
1995
Description:
ii, 11, 2 pages.
Subject:
Drugs--Dosage.
Drugs--Dose-response relationship.
Drugs--Side effects.
Adverse Drug Reaction Reporting Systems--standards.
Data Collection--standards.
Safety Management--standards.
United States.
Guideline.
Other Authors:
United States. Food and Drug Administration. http://id.loc.gov/authorities/names/n80126147
International Conference on Harmonisation. http://id.loc.gov/authorities/names/nr94017915
Notes:
Cover title. "March 1995" "... developed within the Expert Working Group (Efficacy) the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)"--P [1]. Includes bibliographical references (page 11).
Series:
Guideline for industry ; ICH-E2A
OCLC:
(OCoLC)33274327
Locations:
OVUX522 -- University of Iowa Libraries (Iowa City)

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