幼若毒性試験が必要となる事例及び最小となる試験デザインの解説

<p>Juvenile animal studies (JAS) have become important to support pediatric drug development. The guideline for nonclinical safety studies (ICH S11) was issued last year, which states that JAS should be conducted on a case-by-case basis after comprehensively considering several aspects, including development, clinical information, and nonclinical information. In many cases, however, it is difficult to determine whether a study is necessary or not. The ICH S11 study group of JPMA has prepared a collection of case studies on the necessity of JAS and the evaluation of weight of evidence (WoE) as training materials for better understanding of the WoE approach to judge the necessity of JAS. We have also newly developed a decision tree to determine the necessity of JAS. In most cases, it is often decided that JAS are needed when developing medicinal products for children. In this presentation, we will introduce a plan to minimize the study design element and introduce the possibility of avoiding the conduct of the study even when JAS are considered to be required as per the decision tree. In addition, examples of actions to be taken in cases where the decision tree states “reconsider the non-clinical study approach or pediatric development plan” are also explained.</p>