دورية أكاديمية
[Consideration of clinical development for new anticancer drugs on Japan, proposal from approval reviewer].
العنوان: | [Consideration of clinical development for new anticancer drugs on Japan, proposal from approval reviewer]. |
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المؤلفون: | Urano T; Office of New Drugs Evaluation I, Pharmaceuticals Medical Devices Agency. |
المصدر: | Gan to kagaku ryoho. Cancer & chemotherapy [Gan To Kagaku Ryoho] 2007 Feb; Vol. 34 (2), pp. 305-7. |
نوع المنشور: | English Abstract; Journal Article |
اللغة: | Japanese |
بيانات الدورية: | Publisher: Gan To Kagaku Ryohosha Country of Publication: Japan NLM ID: 7810034 Publication Model: Print Cited Medium: Print ISSN: 0385-0684 (Print) Linking ISSN: 03850684 NLM ISO Abbreviation: Gan To Kagaku Ryoho Subsets: MEDLINE |
أسماء مطبوعة: | Publication: Tokyo : Gan To Kagaku Ryohosha Original Publication: Tōkyō, Gan to Kagaku Ryōhōsha [1974?]- |
مواضيع طبية MeSH: | Antineoplastic Agents* , Legislation, Drug*, Drug Approval/*legislation & jurisprudence, Drug Approval/organization & administration ; Drug Utilization Review ; Humans ; Japan ; Licensure ; Marketing ; Time Factors |
مستخلص: | There become problems about a delay on clinical development of anticancer drug in Japan and drug lag. I consider causes and solutions of the problems from a position of drug approval reviewer. I think the drug lag may cause by stating later state in global clinical development or stagnation of clinical trial activities. To prevail against drug lag,it is necessary to attend to multinational clinical studies,and to mature Japanese clinical trial environment and post-market planning. Then, I believe that the most important point is to make a start on early stage of global clinical development. |
المشرفين على المادة: | 0 (Antineoplastic Agents) |
تواريخ الأحداث: | Date Created: 20070216 Date Completed: 20070321 Latest Revision: 20070215 |
رمز التحديث: | 20240829 |
PMID: | 17301550 |
قاعدة البيانات: | MEDLINE |
تدمد: | 0385-0684 |
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