- Impact of Safety-Related Regulatory Action on Clinical Practice A Systematic Review
[作者:Piening, S; Haaijer-Ruskamp, FM; de Vries, JTN; van der Elst, ME; de Graeff, PA; Straus, SMJM; Mol, PGM,期刊:Drug safety, 页码:373-385 , 文章类型: Review,,卷期:2012年35-5]
- Background: After market approval, new serious safety issues are regularly identified for drugs that lead to regulatory action to inform healthcare professionals. However, the effectiveness of these safety-related regula...
- A Pharmacoepidemiological Network Model for Drug Safety Surveillance Statins and Rhabdomyolysis
[作者:Reis, BY; Olson, KL; Tian, L; Bohn, RL; Brownstein, JS; Park, PJ; Cziraky, MJ; Wilson, MD; Mandl, KD,期刊:Drug safety, 页码:395-406 , 文章类型: Article,,卷期:2012年35-5]
- Background: Recent withdrawals of major drugs have highlighted the critical importance of drug safety surveillance in the postmarketing phase. Limitations of spontaneous report data have led drug safety professionals to ...
- Early Steps in the Development of a Claims-Based Targeted Healthcare Safety Monitoring System and Application to Three Empirical Examples
[作者:Wahl, PM; Gagne, JJ; Wasser, TE; Eisenberg, DF; Rodgers, JK; Daniel, GW; Wilson, M; Schneeweiss, S; Rassen, JA; Patrick, AR; Avorn, J; Bohn, RL,期刊:Drug safety, 页码:407-416 , 文章类型: Article,,卷期:2012年35-5]
- Background: Several efforts are under way to develop and test methods for prospective drug safety monitoring using large, electronic claims databases. Prospective monitoring systems must incorporate signalling algorithms...
- A Cohort Study Exploring Determinants of Safety-Related Regulatory Actions for Biopharmaceuticals
[作者:Ebbers, HC; Mantel-Teeuwisse, AK; Moors, EHM; Tabatabaei, FAS; Schellekens, H; Leufkens, HGM,期刊:Drug safety, 页码:417-427 , 文章类型: Article,,卷期:2012年35-5]
- Background: The characteristics of biopharmaceuticals may require a tailored approach to their safety management. However, information on what tools and methods are employed to assess the safety of biopharmaceuticals pos...
- Defining 'Surveillance' in Drug Safety
[作者:Aronson, JK; Hauben, M; Bate, A,期刊:Drug safety, 页码:347-357 , 文章类型: Article,,卷期:2012年35-5]
- The concept of surveillance in pharmacovigilance and pharmacoepidemiology has evolved from the concept of surveillance in epidemiology, particularly of infectious diseases. We have surveyed the etymology, usages, and pre...
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