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Pharmacovigilance (PV, or PhV), also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharmaceutical products. [1]: 7 The etymological roots for the word "pharmacovigilance" are: pharmakon (Greek for drug) and vigilare (Latin for to keep ...
The U.S. Kefauver–Harris Amendment or "Drug Efficacy Amendment" is a 1962 amendment to the Federal Food, Drug, and Cosmetic Act. It introduced a requirement for drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval, [1] [2] required drug advertising to disclose accurate information about side effects, and stopped cheap generic drugs being marketed ...
Case reports have a role in pharmacovigilance. [5] They can also help understand the clinical spectrum of rare diseases as well as unusual presentations of common diseases. [4] They can help generate study hypotheses, including plausible mechanisms of disease. [4]
Lack of efficacy as shown by PROWESS-SHOCK study [19] [20] [21] Ebrotidine: 1998 Spain Hepatotoxicity. [3] Efalizumab (Raptiva) 2009 Germany Withdrawn because of increased risk of progressive multifocal leukoencephalopathy [14] Encainide: 1991 UK, US Ventricular arrhythmias. [2] [3] Ethyl carbamate: 1963 Canada, UK, US Carcinogen. [22 ...
Pharmacovigilance is a type of continual monitoring of unwanted effects and other safety-related aspects of drugs that are already placed in current growing integrating markets. In practice, pharmacovigilance refers almost exclusively to spontaneous reporting systems which allow health care professionals and others to report adverse drug ...
Because of the lack of these data and uncertainty about methods for synthesising them, individuals conducting systematic reviews and meta-analyses of therapeutic interventions often unknowingly overemphasise health benefit. [5] To balance the overemphasis on benefit, scholars have called for more complete reporting of harm from clinical trials. [6]
Where the Secretary of State for Environment, Food and Rural Affairs considers, as a result of the evaluation of veterinary pharmacovigilance data that there is a significant safety concern, the marketing authorisation may be suspended, revoked or varied to restrict the indications, change the distribution category, amend the dose, add a ...
A data monitoring committee (DMC) – sometimes called a data and safety monitoring board (DSMB) – is an independent group of experts who monitor patient safety and treatment efficacy data while a clinical trial is ongoing.