Reply from Ken-ichi Fujita

Ken-ichi Fujita — Mon, 10 Mar 2008 23:58:46 -0000

1. It should depend on pharmacokinetic and pharmacodynamics properties of a certain drug. For example, a drug that is predominantly metabolized by a highly polymorphic CYP2A6, which is responsible for the metabolism of nicotine, should be affected by smoking behavior.
2. Currently, we still do not have appropriate database with enough information to predict clinical outcome or dose of a drug. We have to perform systematic and effective researches to find them. Biomarker researches have to be included.
3. If patients are treated with a drug solely metabolized by a specific CYP isoform, it is necessary to avoid the concurrent administration of drugs that are metabolized by the same isoform of CYP and also to minimize the use of herbal supplements that are considered to be contained components which are metabolized by the form of CYP or induce the CYP. For example, taking SUSTIVA with St. John’s wort (Hypericum perforatum) is not recommended as it may cause decreased levels of SUSTIVA, increased viral load, and possible resistance to SUSTIVA or cross-resistance to other anti-HIV drugs.
4. As described in the Pharmacoecology manuscript, it depends on the life style of a patient. Pharmacokinetic profiles are important to avoid the accumulation of the drugs for shift workers.
5. It may be very difficult, but need to be regulated consistently by rules to be established in the future.
6. In Japan, diet supplements are classified as foods. Therefore, the diet supplement should clear the product criteria established for foods by Ministry of Health, Labour and Welfare for approval. In general, components of therapeutic drugs such as ephedrine are not contained in the approved supplements. However, there is no criterion to check the contamination of dangerous drug components such as ephedrine and steroid.
7. It should be vary convenient for clinicians to make better decision for prescription.
8. The future population-level evidence from trial should be contained lines of information for personalized medicine including not only PK/PD/PGx but also a variety of other biomarkers.
9. It may be necessary to perform clinical trials including populations with various genetic back grounds and environment factors.
10. Drug manufacture should consider both of suppliers and intermediaries as well as labeling and certification.

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Reply from Ken-ichi Fujita