Problems of post-marketing surveillance.
نویسندگان
چکیده
منابع مشابه
Post-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...
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Post-marketing safety studies are an important tool for understanding and monitoring the safety profiles of drugs in the clinical setting. Their importance has attracted not only the attention of regulators for reinforcing legislation but also led to recent changes in European Union (EU) regulations; these regulations have influenced the practice of Post-Authorization Safety Study (PASS) by mar...
متن کاملPost marketing surveillance of sublingual buprenorphine naloxone combination tablets.
BACKGROUND & OBJECTIVES A combination of buprenorphine-naloxone (Addnok-N) tablets has been recently introduced in India as treatment for Opioid dependence. This study was undertaken to evaluate the possible adverse consequences following use of the buprenorphine-naloxone tablets through post marketing surveillance. METHODS National Drug Dependence Treatment Centre (NDDTC), AIIMS, India, moni...
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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...
متن کاملPost marketing surveillance on medical implants in neurosurgery.
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: British Journal of Clinical Pharmacology
سال: 1983
ISSN: 0306-5251
DOI: 10.1111/j.1365-2125.1983.tb02225.x