(Case 2)In this case, the calculation of the clinical initial dose was used the MABEL based on applied pharmacodynamic (PD) test using cynomolgous monkey as an animal model, which is determined by knowledge of the histological distribution of the target molecules on the mode of action, in vitro studies and so on, because the target is a novel molecule. (事例 2) 新規の標的分子のため,標的分子の組織分布,in vitro の知見等で動物モデルとして選択されたカニクイザルを用いた薬力学(PD)的試験から MABEL を基準とした初回投与量を算出した. - 厚生労働省