The consequences of drug misuse on post-marketing surveillance
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...
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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...
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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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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...
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Neurosurgeons deal with the most vulnerable human organ, the central and peripheral nervous system (CNS and PNS): the brain and its efferent and afferent neural structures (spinal cord), and peripheral nerves. Also, the CNS blood vessel system as well as the CNS surrounding structures, like the membranes covering the CNS tissue and the bony elements enveloping the CNS (skull and spinal column),...
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ژورنال
عنوان ژورنال: Expert Review of Clinical Pharmacology
سال: 2016
ISSN: 1751-2433,1751-2441
DOI: 10.1080/17512433.2016.1178571