Abstract
We have performed in our department Phase I Studies on various drugs, ten of which were originally investigated in Japan. For these domestic drugs, preclinical animal studies concerning toxicology, teratology, general pharmacology, efficacy supporting, and pharmacokinetis are discussed herein. Most of the drugs were to be used in man for the first time, so the initial dose was carefully determined based upon the results of animal studies. The criteria for determination of initial are then presented and discussed. One of the ten drugs showed a marked difference in pharmacokinetics between animals and human. The Phase I Study on this drug is presented as an example.
