Document Detail

How pre-marketing data can be used for predicting the weight of drug interactions in clinical practice.
MedLine Citation:
PMID:  23279878     Owner:  NLM     Status:  Publisher    
Unexpected drug interactions have led to the withdrawal of many drugs, raising concern about the gap between what is known at the time of approval and the risk of serious effects in the longer term, particularly in high-risk populations generally excluded from drug development. This is because the majority of drug interaction studies are done using in vitro methods, or in healthy young volunteers who may not reflect the complexity of patients, and the settings in which the drug will be used in clinical practice. Pre-marketing interaction studies should therefore be designed to make information easily accessible and clinically transferable. They should be adequate in terms of sample size, population, comorbidity, phenotyping and/or genotyping, end-points and outcome measures, and conducted in conditions of dose, route and timing of co-administration that reproduce the proposed therapeutic indications of the new drug. Although young volunteers have the advantage of minimizing some confounding effects introduced by diseases or polypharmacy, patients drawn from populations for whom the drug is intended would be more relevant and accurate, providing the studies are feasible and safe.
Silvio Caccia; Luca Pasina; Alessandro Nobili
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-12-29
Journal Detail:
Title:  European journal of internal medicine     Volume:  -     ISSN:  1879-0828     ISO Abbreviation:  Eur. J. Intern. Med.     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2013-1-2     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9003220     Medline TA:  Eur J Intern Med     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2012. Published by Elsevier B.V.
Laboratory for Quality Assessment of Geriatric Therapies Services, Istituto di Ricerche Farmacologiche, "Mario Negri," Milan, Italy.
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