کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
2578944 | 1130021 | 2013 | 6 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Pharmacoepidemiology Studies: what Levels of Evidence and how can They be Reached?
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کلمات کلیدی
HASEGBSNIIRAMAes - AESAdverse effects - اثرات جانبیEffectiveness - اثربخشیevaluation - ارزیابیGrading of Recommendations Assessment, Development and Evaluation - ارزیابی توصیه ها، توسعه و ارزیابیRisk - خطرLevel of evidence - سطح شواهدMarketing authorization - مجوز بازاریابیGrade - مقطع تحصیلیDatabases - پایگاه داده ها
موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
فارماکولوژی، سم شناسی و اقلام دارویی (عمومی)
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چکیده انگلیسی
In pharmacoepidemiology studies, the nature of the research question will dictate the choice of methodological approach and the conditions for optimizing the level of evidence. Thus, to document the treated population and the modes of use of a new drug in real-life prescribing conditions, a descriptive approach through cross-sectional or longitudinal studies conducted on databases, or else ad-hoc studies, will be preferred. On the other hand, evaluation of the real-life “effectiveness” of a new drug will be based on cohort, case-control or scientific modeling, depending on the drug and the disease of interest. For questions involving drug risks and safety, it is the adverse effects profile that will guide the choice of study design, both for identification of the effect (signal) and assessment of causation. In all cases, in the post-marketing authorization (MA) setting, the evidence acquired in pre-MA studies serves as the basis for generating hypotheses. Whatever the research question and the method chosen to address it, the potential biases and their impact on the results need to be identified. In certain cases, a combination of several complementary approaches may prove preferable to a single study.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Thérapie - Volume 68, Issue 4, JulyâAugust 2013, Pages 247-252
Journal: Thérapie - Volume 68, Issue 4, JulyâAugust 2013, Pages 247-252
نویسندگان
Maryse Lapeyre-Mestre, Claudine Sapède, Nicholas Moore, participants of round table N° 5 of Giens Workshops XXVIII: participants of round table N° 5 of Giens Workshops XXVIII:, Pascal Bilbault, Patrick Blin, Damien Chopy, David Evans,