[The present status and problems of phase III clinical trials of the new anti tumor drug-pharmaceutical company's view].
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.
Yamada
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Daiichi Pharmaceutical Co., LTD. Medical Information Dept. II.
D000970:Antineoplastic Agents; D002985:Clinical Protocols; D017326:Clinical Trials, Phase III as Topic / Q000639:trends; D017410:Practice Guidelines as Topic; D013678:Technology, Pharmaceutical
D000970:Antineoplastic Agents