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 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 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 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...
متن کاملPost Marketing Surveillance on Propranolol and Atenolol Tablets Manufactured in Iran
Propranolol, a prototypical b-adrenergic receptor antagonist and atenolol, a cardio-selective b-antagonist are widely used in therapeutic regimens for treatment of hypertensive patients. In Iran, several pharmaceutical manufacturers formulate these two b-blockers. As the formulation of a dosage form is essential for the patient's safety and drug efficacy, in this study we aimed to evalu...
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ژورنال
عنوان ژورنال: British Journal of Clinical Pharmacology
سال: 1978
ISSN: 0306-5251
DOI: 10.1111/j.1365-2125.1978.tb04584.x