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The EMA has released a concept paper for a guideline on pharmacogenomic methodologies in the evaluation of authorized medicines to address the fact that genetic differences can cause variability in drug therapy efficacy and safety.
The EMA has released a concept paper for a guideline on pharmacogenomic methodologies in the evaluation of authorized medicines to address the fact that genetic differences can cause variability in drug-therapy efficacy and safety. The limited scope of clinical trials means that rare but serious adverse drug reactions (ADRs) may not be discovered until after increased population exposure post authorization.
Included in the topics proposed for the guideline are the following:
The EMA press release stated, “Identifying individuals at risk of side effects, unexpected complications or lack of efficacy may help the development of strategies to optimize the use of medicines.” The concept paper is open for public consultation until Mar. 15, 2012.