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The “Guideline on Population Pharmacokinetic and Pharmacodynamic Analysis” has been published in the “Notification of Guideline on Population Pharmacokinetic and Pharmacodynamic Analysis” (PSEHB/PED Notification No. 0515-1, by the Director of the Pharmaceutical Evaluation Division, Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labor and Welfare, dated May 15, 2019)
In clinical drug development, phase I clinical trials are generally conducted to evaluate the tolerability, safety and the basic pharmacokinetic profile of the drug, and to investigate the exploratory pharmacokinetics and pharmacodynamics of the drug in healthy volunteers.