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Postmarketing Surveillance in Canada
Drug Information Journal, 1996This paper provides an overview of the history of Canada's adverse drug reaction monitoring program. The program's place within Health Canada is covered, as are development activities over the last five years. Further intentions and international harmonization initiatives are highlighted.
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Postmarketing Surveillance of Drugs*
2020Most efforts in postmarketing surveillance are directed at the design of methods to collect information on newly marketed drugs. In the review by Medicine in the Public Interest the majority of fatal adverse reactions seemed to be due to older, standard drugs.
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Concerns with postmarketing surveillance
American Journal of Health-System Pharmacy, 1984M J, Norvell, R J, Anderson
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Postmarketing surveillance--some ethical considerations.
The Journal of rheumatology. Supplement, 1989While postmarketing surveillance presents many of the ethical problems characteristic of research involving human subjects, this article focuses on some of the more frequently encountered issues: It is necessary to distinguish research from practice because ethical justification for these two classes of activity differs in important respects.
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[Postmarketing surveillance on Benazepril].
Zhonghua liu xing bing xue za zhi = Zhonghua liuxingbingxue zazhi, 2005To investigate the long-term effect, safety and tolerability of benazepril in general hypertensive patients.We conducted a three-year community-based postmarketing surveillance on benazepril among 1831 essential hypertensive patients (age range from 35 to 88 years) in Shanghai.74.3% of patients persisted in medication taking and were with optimal ...
Jun, Lu +4 more
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Postmarketing Safety Surveillance
Pharmaceutical Medicine, 2010Upasana Prabhakar, Brian Edwards
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Postmarket surveillance. Final rule.
Federal register, 2002The Food and Drug Administration (FDA) is implementing the postmarket surveillance (PS) provisions of the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). The purpose of this rule is to provide for the collection of useful data about devices that can reveal unforeseen ...
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Postmarketing drug surveillance studies
Clinical Pharmacology and Therapeutics, 1991openaire +2 more sources