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Drug Safety Evaluation and Pharmacovigilance

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While the regulatory bodies have well established regulatory statutes, sandards of ascertaining safety are heterogeneous (Edwards & Tilson, 2005). Tere is limited statistical power in determining the specific harm due to lack of statistical significance in the selected population. Te selected patient group is small and excludes patients who are at a greater risk. Tere is limited generalizability since the study participants are carefully selected. Tere is a strict criterion of selecting whom to include and whom to exclude. As a result, te participants may not be representative of entire population, hnce unreliable results.

I most cases, te duration of trial treatment is not adequate for adverse events to show. De to difference in a dynamic reaction to drugs of each individual, sme symptoms may not manifest during limited treatment duration (Levine, 1994). In most cases of trial treatment, dses are restricted. I the test designed to measure a particular single dose, tere is no data on dose responsiveness. Tis makes it difficult to extrapolate the safety information to wider populations who might be taking different doses 2012).

Cinical trials require an experienced specialist who undertakes the research project to give reliable information that can be used to determine whether the drug is safe or not. Lck of experience and specialization in a particular field has lead to misleading adverse events, hnce risking of human life. Tere is lack of adequate classification and ascertainment of adverse occurrences, de to failuire in close monitoring of patients and recording of the actual observations. Fr example, were outcomes are by spontaneous reports from participants rather than actual monitoring, ms-classification adverse outcomes is possible (Rodighiero, 1999).

Tere exist some differences between pre-marketing and post-marketing clinical experiences. Pe-marketing involves a small number of participants while post-marketing incorp[orates a larger population who are using the drug. I pre-marketing, te duration and types of patients are limited and restricted respectively unlike in post-marketing where they are controlled statistically. Pst-marketing does not require specialists to monitor the process and the patient monitoring level is low, ulike clinical trials where the level of monitoring is high and requires experienced specialists. I today’s modern regulatory...

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