AI Article Synopsis
- Pharmacotherapy exhibits significant variations in how different individuals process and respond to drugs, affecting both their effectiveness and the likelihood of side effects.
- Recent advances in genetic research have identified genetic polymorphisms as key factors contributing to these differences, offering potential for tailored treatments.
- Regulatory guidelines have emerged in the EU and US to facilitate the integration of pharmacogenomic data into drug development, as demonstrated by Tohoku University's research on genetic variations in drug metabolism within Japanese populations.
Article Abstract
Pharmacotherapy shows striking individual differences in pharmacokinetics and pharmacodynamics, involving drug efficacy and adverse reactions. Recent genetic research has revealed that genetic polymorphisms are important intrinsic factors for these inter-individual differences. This pharmacogenomic information could help develop safer and more effective precision pharmacotherapies and thus, regulatory guidance/guidelines were developed in this area, especially in the EU and US. The Project for the Promotion of Progressive Medicine, Medical Devices, and Regenerative Medicine by the Ministry of Health, Labour and Welfare, performed by Tohoku University, reported scientific information on the evaluation of genetic polymorphisms, mainly on drug metabolizing enzymes and transporters, during non-clinical studies and phase I clinical trials in Japanese subjects/patients. We anticipate that this paper will be helpful in drug development for the regulatory usage of pharmacogenomic information, most notably pharmacokinetics.
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| http://dx.doi.org/10.1016/j.dmpk.2018.01.005 | DOI Listing |
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