Journal article icon

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...

Expand abstract

Actions


Access Document


Authors


Holmes, WF More by this author
More by this author
Institution:
University of Oxford
Department:
Oxford, MSD, Population Health
Journal:
International Journal of Pharmaceutical Medicine
Volume:
16
Issue:
4
Pages:
167-169
Publication date:
2002-08-05
DOI:
ISSN:
1364-9027
URN:
uuid:41481a53-9962-4c6b-ba45-cd083f73e3b8
Source identifiers:
162352
Local pid:
pubs:162352
Language:
English

Terms of use


Metrics



If you are the owner of this record, you can report an update to it here: Report update to this record

TO TOP