Research and development is a part of pharmaceutical
companies. Every time they focus to develop new drugs. With new drug development, comes the responsibility to check whether it is safe or not,
whether it is formed as per the needs of its clients or not, whether the drug
is safe or not and whether it is the one the scientist were trying to create.
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Post market drug safety is a general term used to describe
the research and studies associated with product safety evaluation after a drug
has been approved for marketing. It aims to monitor the use of a drug in a
large no of patients after marketing to evaluate adverse events/ adverse drug
reactions in order to continuously analyze its benefit or the risk ratio. It
usually include the collection, reporting and evaluation of adverse experience
reports: the analysis of drug use data to calculate reporting rates; and the conduct of epidemiologic and
other studies to better quantitative the public health importance of these
events. The overall purpose of post market drug safety is to develop new safety
information on a drug as it is used in the market place or in real world
clinical practice.
Clinical trials are the backbone of the drug approval
process and are designed to determine drug efficacy and toxicity. Post market drug safety complements
pre-marketing clinical trials. It should be noted that both clinical trials and
post marketing surveillance contribute for the understanding of drug safety. The various
characteristics of clinical trial methodology are: Specific number of
participants, Short duration, Non representative patient selection, Narrow drug
indication or limited indications, Limited concomitant drug use and higher
level of patient compliance. These
characteristics are discussed in detail with more focus on the fact that how
post marketing surveillance provides complimentary data. These include size,
clinical trial duration, patient selection, drug indications, concomitant drugs
and patient compliance.
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