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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.
VigiBase is a World Health Organization's (WHO) global Individual Case Safety Report (ICSR) database that contains ICSRs submitted by the participating member states enrolled under WHO's international drug monitoring programme. It is the single largest drug safety data repository in the world.
The Pharmacovigilance Program makes these reports itself, but ideally, such reports could originate from any clinic. [3] The Pharmacovigilance Programme seeks to encourage a culture and social expectation of reporting drug problems. [3] One of the successes of the program was detecting adverse effects of people in India using carbamazepine.
In medicine, a case report is a detailed report of the symptoms, signs, diagnosis, treatment, and follow-up of an individual patient. Case reports may contain a demographic profile of the patient, but usually describe an unusual or novel occurrence. Some case reports also contain a literature review of other reported cases.
Postmarketing surveillance (PMS), also known as post market surveillance, is the practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of pharmacovigilance.
Originally all case report forms were made on paper. But recently there is a changing trend to perform clinical studies using an electronic case report form (eCRF). This way of working has many advantages: Faster and more efficient; High security; Environmentally friendly
Type A: augmented pharmacological effects, which are dose-dependent and predictable [5]; Type A reactions, which constitute approximately 80% of adverse drug reactions, are usually a consequence of the drug's primary pharmacological effect (e.g., bleeding when using the anticoagulant warfarin) or a low therapeutic index of the drug (e.g., nausea from digoxin), and they are therefore predictable.
Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), is a United States Supreme Court case determining the standard for admitting expert testimony in federal courts. In Daubert , the Court held that the enactment of the Federal Rules of Evidence implicitly overturned the Frye standard ; the standard that the Court articulated is referred to ...