Pharmacoepidemiology and drug safety
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Pharmacoepidemiol Drug Saf · Sep 2002
Postmarketing drug dosage changes of 499 FDA-approved new molecular entities, 1980-1999.
Risks and benefits of marketed drugs can be improved by changing their labels to optimize dosage regimens for indicated populations. Such postmarketing label changes may reflect the quality of pre-marketing development, regulatory review, and postmarketing surveillance. We documented dosage changes of FDA-approved new molecular entities (NMEs), and investigated trends over time and across therapeutic groups, on the premise that improved drug development methods have yielded fewer postmarketing label changes over time. ⋯ Dosages of one in five NMEs changed, four in five changes were safety reductions. Increasing frequency of changes, independent of therapeutic group, may reflect intensified postmarketing surveillance and underscores the need to improve pre-marketing optimization of dosage and indicated population.
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Pharmacoepidemiol Drug Saf · Sep 2002
Comparative StudyPresence of pharmacoepidemiology in three bibliographic databases: Medline, IPA and SCI.
The objective of this study is to make a comparative description of the evolution and distribution of international research into pharmacoepidemiology, using three bibliographic databases, in order to select the most appropriate for future bibliometric studies. ⋯ International research into pharmacoepidemiology presents an exponential growth pattern, in accordance with Price's law. There is a large degree of publishing dispersion. IPA was found to be the bibliographic database that recovered the greatest number of original articles, nearly half of which were published in Pharmacoepidemiology and Drug Safety. We therefore consider the latter database appropriate for bibliometric studies in the field of pharmacoepidemiology.