Drug Safety Evaluation and Pharmacovigilance Assignment

Drug Safety Evaluation and Pharmacovigilance - Assignment ExampleThe systems that are used to quantify post-marketing events include medical record databases or computerized claims, reports and pre marketing studies.Drug toxicity is frequently a major safety issue for an investigational hot drug. This may occur as an unexpected reaction to a harmless drug or it may be an expected consequence of the intrinsic toxicity of a drug, interpreted in a sufficiently large dose (Berlin, 2008). It is the function of pharmaceutical research companies to take the grade from understanding a disease to bringing a safe and effective treatment to patients. To ensure that assemblage of data is complete and to protect the safety of canvass participants, various processes are put in tramp during clinical trials (Meadows, 2006). The completeness of data is important in developing an understanding of the advantages and side effects of a new medicine (Meadows, 2006). With one or more solutions at h and, researchers turn their attention to testing them extensively to deposit if they should move on to testing in humans.Efficacy and safety of investigational new drugs have an inherent insufficiency in the inability to detect major, rare and adverse effects (Talbot, 2011). The limitations of these safety data for predicting post confidence safety profiles must be a consideration. These pre-marketing clinical trial limitations include lack of globally recognised gold standards for determining whether a signal on drug safety represents true risk. While the regulative bodies have well established regulatory statutes, standards of ascertaining safety are heterogeneous (Edwards & Tilson, 2005). There is limited statistical power in determining the specific harm due to lack of statistical significance in the selected population. The selected patient group is small and excludes patients who are at a greater risk.There is limited generalizability since the study participants are caref ully selected. There is a strict criterion of selecting whom to include