Document Detail


Regulatory Innovation in Postmarketing Risk Assessment and Management.
MedLine Citation:
PMID:  22297386     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
The contemporary science of drug safety seeks not only to identify the risks associated with the use of medicines but also to quantify these risks, identify their risk factors, and assess strategies to minimize them. It monitors the use of medicines in actual practice to understand how the medical care system interacts with the intrinsic pharmacologic properties of medicines to produce the observed effects. To the extent possible, these analyses use a population-based approach that at times requires creativity and innovation. The key to effective safety management of drugs in the postmarketing setting is the ability to access sufficient good-quality data, interpret the data appropriately, challenge old assumptions, and define best practices in contemporary drug safety approaches.
Authors:
J A Staffa; G J Dal Pan
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-2-01
Journal Detail:
Title:  Clinical pharmacology and therapeutics     Volume:  -     ISSN:  1532-6535     ISO Abbreviation:  -     Publication Date:  2012 Feb 
Date Detail:
Created Date:  2012-2-2     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0372741     Medline TA:  Clin Pharmacol Ther     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
Office of Surveillance and Epidemiology, US Food and Drug Administration, Silver Spring, Maryland, USA.
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