Regulatory Innovation in Postmarketing Risk Assessment and Management

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 c...

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Bibliographic Details
Published in:Clinical pharmacology and therapeutics 2012-03, Vol.91 (3), p.555-557
Main Authors: Staffa, J A, Dal Pan, G J
Format: Article
Language:English
Subjects:
Biological and medical sciences
Clinical trial. Drug monitoring
Drug Monitoring
Drug-Related Side Effects and Adverse Reactions
General pharmacology
Humans
Medical sciences
Pharmacology. Drug treatments
Product Surveillance, Postmarketing - methods
Product Surveillance, Postmarketing - standards
Risk Assessment
Risk Factors
Risk Management
Statistics as Topic
Substance-Related Disorders
United States
United States Food and Drug Administration
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Summary: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. Clinical Pharmacology & Therapeutics (2012); 91 3, 555–557. doi:10.1038/clpt.2011.289
ISSN:0009-9236
1532-6535
DOI:10.1038/clpt.2011.289