The EMA has published has published a guideline advising pharmaceutical companies how to integrate studying the role of genetic variability between patients during development of medicines.
The guidelines clarifies the requirements of the effect of genetic variability on the way of human body handles medicines. This includes how genetic variation can affect the absorption, distribution, metabolism and excretion of medicines by the body, which can in turn lead to differences in the benefits and risks of a medicines between individuals.
The guideline sets out the requirements and recommendations on:
- When pharmacogenetic studies should be performed;
- How these studies should be designed and carried out;
- How the clinical impact of genetic difference between patients should be evaluated;
- How dosing or treatment recommendations for genetic sub-populations should be studies;
- Consequences for treatment recommendations and labeling;
- The impact if interactions between medicines and of impaired or immature organ functions.
The guideline is adopted (19 Jan 2012) by the Committee for Medicinal Products for Human Use after incorporation of comments from the public consultation phase.
Companies applying for marketing authorization should follow the guideline from 1 Aug 2012.
No comments:
Post a Comment