抄録
Toxicological data is an important reference to estimate the safety in the early phase of clinical trials. Especially, in the First in Human trials, the role of toxicological data is more crucial and principal investigator has to presume which point should be paid more attention according to the data. On the other hand, in the later phase of trials, it is not so frequent to be paid attentions to the non-clinical data, unless some severe adverse event occurred, which gives us opportunity to look back to it.
In my talk, I would like to examine the possibility to make the most of non-clinical (toxicological) data not only in the early phase of clinical trials, but also later phase or post-marketing stage by comparing safety data between non-clinical and clinical (trial and post-marketing stage) of some drugs. Moreover, I would like to consider the necessity of new biomarker as a more accurate indicator which will link non-clinical data and clinical safety assessment.
