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Safety Assessment of Marketed Medicines (SAMM) studies: Problems addressed but problems raised?

Abstract:

SAMM studies, when properly conducted, can provide rapid accrual of safety data for the regulatory authorities, the pharmaceutical company and health care professionals. Results should be made widely available, either through peer-reviewed papers or on the web. A SAMM PMS study should include a comparator group but the question of randomization remains open to discussion. If randomization is decided upon, the study should be submitted for ethical review, but the ethics committees must be awar...

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Institution:
University of Oxford
Division:
MSD
Department:
Nuffield Department of Population Health
Sub department:
Population Health
Role:
Author
Journal:
International Journal of Pharmaceutical Medicine
Volume:
16
Issue:
4
Pages:
167-169
Publication date:
2002-08-01
DOI:
ISSN:
1364-9027
Language:
English
Pubs id:
pubs:162352
UUID:
uuid:41481a53-9962-4c6b-ba45-cd083f73e3b8
Local pid:
pubs:162352
Source identifiers:
162352
Deposit date:
2012-12-19

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