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Monday, June 26, 2017
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Is Pharmacovigilance Only Important During Clinical Trials?

Clinical trials are important steps needed to capture the nature of newly developed drugs, particularly when it comes to significant side effects. However, after the clinical trials are completed, this does not mean that this data is not sought afterwards. Pharmacovigilance is important even after the drug has been licensed for use by the public long after it has been developed.

This is because some of the side effects of some drugs will only manifest when they are used for a long time. Long term use of such drugs may not be replicated during the clinical trials, so this information can only be obtained through pharmacovigilance when the drug is being used by the public. The information can then be used to make decisions such as how to modify the drug in order to reduce the side effect profile.

Differences in the physiology of different individuals can also affect how they metabolize the drug, which could in turn result in other unexpected side effects. Once again, this is something that may not be captured during the clinical trials, but will be easier to get when the drug is used by many members of the public. This information can then be used to update the criteria for use of the drug. For instance, if it turns out that people with specific illnesses cannot tolerate the drug, then that illness can be deemed a contraindication for use of the drug.

In summary, pharmacovigilance is important even after the clinical trials are over, and ensures that as much information as possible is known about the drug.

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