Journal article
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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Bibliographic Details
- Journal:
- International Journal of Pharmaceutical Medicine
- Volume:
- 16
- Issue:
- 4
- Pages:
- 167-169
- Publication date:
- 2002-08-01
- DOI:
- ISSN:
-
1364-9027
Item Description
- 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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- Copyright date:
- 2002
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