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Drug Safety Evaluation and Pharmacovigilance - Assignment Example

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The challenges of safety data in clinical trials include lack of standard and limited generalizability of trials that exclude patients that…
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Drug Safety Evaluation and Pharmacovigilance
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"Drug Safety Evaluation and Pharmacovigilance"

Download file to see previous pages The systems that are used to assess 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 new drug. This may occur as an unexpected reaction to a nontoxic drug or it may be an expected consequence of the intrinsic toxicity of a drug, taken in a sufficiently large dose (Berlin, 2008). It is the function of pharmaceutical research companies to take the path from understanding a disease to bringing a safe and effective treatment to patients. To ensure that collection of data is complete and to protect the safety of study participants, various processes are put in place 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 hand, researchers turn their attention to testing them extensively to determine if they should move on to testing in humans.
Efficacy and safety of investigational new drugs have an inherent deficiency in the inability to detect major, rare and adverse effects (Talbot, 2011). The limitations of these safety data for predicting post authorization safety profiles must be a consideration. These pre-marketing clinical trial limitations include lack of globally accepted gold standards for determining whether a signal on drug safety represents true risk. While the regulatory 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 carefully selected. There is a strict criterion of selecting whom to include ...Download file to see next pagesRead More
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