The reason such a review is needed periodically is because clinical trials tend to be of short duration and to include a limited number of patients.
PURPOSE OF THE PSUR
The
PSUR creates the opportunity for a periodic overall safety evaluation to show
whether a product’s safety profile has remained the same or has undergone
change since it was authorised and to indicate whether changes should be made
to product information to optimise the use of a product. The reason such a
review is needed periodically is because clinical trials tend to be of short
duration and to include a limited number of patients. Moreover, clinical trials
have inclusion and exclusion criteria. After a product is launched, it may be
used by patients not studied in clinical trials, for example children, the
elderly, pregnant or breastfeeding women or patients with comorbidities such as
hepatic or renal disease. After approval, a drug becomes so available for
immediate use in large populations, so rare adverse drug reactions (ADRs) can
be more easily identified. The drugs also become available for indefinite use
(unless prescribing information indicates otherwise), and delayed onset ADRs
become easier to identify.
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