Post-marketing surveillance (Phase IV drug studies)
نویسندگان
چکیده
منابع مشابه
Japanese Physicians’ Views on Drug Post-Marketing Surveillance
BACKGROUND Registration trials leading to the approval of drugs are paramount in drug development. After approval, continuous efforts are necessary to ensure proper use of the approved drugs. In Japan, post-marketing surveillance (PMS) by drug companies is conducted in accordance with good post-marketing study practice (GPSP). Although the global standard for pharmacovigilance is incorporated i...
متن کاملRole of the post-marketing authorisation studies in drug risk surveillance: specifications and methodologies.
Studies conducted after the marketing authorisation with the objective of identification, characterization or quantification of one or more risks (called PASS "Post-Authorisation Safety Studies"), have been strengthened in the past years with the implementation of the concept of risk management plans (RMPs), established in 2005 in the European regulatory framework and recently amended as part o...
متن کاملPost-marketing surveillance of buprenorphine.
PURPOSE This study was undertaken to evaluate the adverse consequences of recently introduced higher strength (0.4 and 2.0 mg per tablet) buprenorphine in Indian market. Buprenorphine, a partial opiate agonist and antagonist, is an emerging alternative to methadone as an agent for long-term treatment of opiate dependence. METHODS The current investigation was conducted through a multi-centric...
متن کاملCyclosporine A in juvenile idiopathic arthritis. Results of the PRCSG/PRINTO phase IV post marketing surveillance study.
OBJECTIVE To investigate the clinical use patterns, clinical effect and safety of cyclosporine A (CSA) in juvenile idiopathic arthritis (JIA) in the setting of routine clinical care. METHODS An open-ended, phase IV post marketing surveillance study was conducted among members of the Pediatric Rheumatology Collaborative Study Group (PRCSG) and of the Paediatric Rheumatology International Trial...
متن کاملAn Information Technology Architecture for Drug Effectiveness Reporting and Post-Marketing Surveillance
Adverse drug events impose a large cost on the society in terms of lives and health care costs. In this article, we propose an information technology architecture for enabling the monitoring of adverse drug events in an outpatient setting as a part of the post marketing surveillance program. The proposed system architecture enables the development of a Web-based drug effectiveness reporting and...
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ژورنال
عنوان ژورنال: Psychiatric Bulletin
سال: 1994
ISSN: 0955-6036,1472-1473
DOI: 10.1192/pb.18.2.115