Yamada A
Daiichi Pharmaceutical Co., LTD. Medical Information Dept. II.
Gan To Kagaku Ryoho. 1995 Feb;22(3):323-7.
Daiichi Pharmaceutical Co., Ltd. obtained the Japanese manufacturing approval of irinotecan hydrochloride (CPT.-11) in January 1994, which was developed through the collaboration with Yakult Honsha Co., Ltd. Prior to the approval, the manufacturer submitted to the Japanese MHW the draft protocols for phase III studies of the drug required to be conducted after its approval under the Guidelines for the Clinical Evaluation of Anti-tumor Drugs, which was promulgated in February 1991. As these studies were to be conducted as part of post-marketing surveillance, the manufacturer encountered various types of questions and complicated problems in designing the studies. Thus, the present report describes the pharmaceutical company's view on the present status and problems of phase III studies of novel anti-tumor drugs in Japan.
第一制药株式会社于1994年1月获得盐酸伊立替康（CPT-11）的日本生产许可，该药物是与养乐多本社合作研发的。在获批之前，制造商根据1991年2月颁布的《抗肿瘤药物临床评价指南》，向日本厚生省提交了该药物获批后需进行的III期研究方案草案。由于这些研究将作为上市后监测的一部分进行，制造商在设计研究时遇到了各种问题和复杂情况。因此，本报告阐述了该制药公司对日本新型抗肿瘤药物III期研究现状及问题的看法。
