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Japan Starts Microdose Clinical Trials

This article was originally published in PharmAsia News

Executive Summary

Japan plans to conduct a three-year microdose clinical trial. Contracted by the New Energy and Technology Development Organization, an independent administrative agency, the experiment is conducted by Tokyo University, contract research organizations and pharmaceutical companies. The trial will administer microdoses (1/100th of standard dosage) of 20 approved drugs to patients and use radio isotope or positron emission tomography to examine drug absorption, distribution and metabolism. The purpose is to verify whether microdoses can forecast drugs' efficacy and adverse effects. Japan's Ministry of Health, Labor and Welfare last June released a guidance regarding obtaining patients' informed consent in microdose trials. (Click here for more - Japanese language



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