Gan to kagaku ryoho. Cancer & chemotherapy
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Gan To Kagaku Ryoho · Feb 1998
Clinical Trial[Efficacy of combination of ondansetron injection and tablet in CAF-induced emesis in breast cancer patients].
Efficacy of combination of ondansetron injection and tablet on CAF (cyclophosphamide, adriamycin, 5-fluorouracil) induced emesis were investigated in 10 breast cancer patients (33 courses). Complete suppression rate of nausea or vomiting were approximately 75%, approximately 90% respectively for every treatment day. According to judgement criteria, antiemetic rate of approximately 100% was achieved during the study period. ⋯ In this investigation, combination of ondansetron injection and tablet was shown to sufficiently suppress CAF-induced nausea and vomiting, and their efficacy was confirmed. Still, the study suggested that number of emetic episodes or degree of anorexia differs according to each individual. Therefore we regard additional administration of ondansetron or concomitant use of steroids should be considered when necessary.
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Gan To Kagaku Ryoho · Feb 1998
[Development of an anticancer drug in Japan based on a new clinical trial system].
According to the revision of Pharmaceutical Affairs Law in 1996, the GCP has been enacted into the law. Next year the new GCP was established based on the ICH-GCP and it has been active since April, 1997. Though the new GCP makes it possible for the regulatory authorities (Japan, the United States and European Union) to accept clinical trial data mutually, the circumstances of clinical trial in Japan have been required big changes. ⋯ At the first time, in this article are described the process of both the revision of Japanese pharmaceutical law and the establishment of the new Japanese GCP. The second, the characteristics of the new Japanese GCP especially about the roles and responsibilities of investigators are discussed. Furthermore approaches of the US FDA for new anticancer drugs development are also described.