四、有十大医药先进国家之一参与之多国多中心第三期临床试验(Phase III study),且其试验报告将向美国FDA或欧盟EMA申请查验登记之临床资料,并符合下列条件之一者:
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He cautioned, however, that the findings of the 25-site trial with 167 subjects, require verification in a larger, Phase III study.
他也警告,不管怎样,这个25处场所对167个实验者的结果,还需要更大量的证实,在第三阶段的研究。
There are other efforts under way on the antibody front, including a joint venture between Wyeth and Elan that is headed for Phase III study later this year.
还有其他在抗体方面的努力在进行中,包括今年晚些时候将进行II I期临床的惠氏和Elan公司的联合风险投资研究。
The results come from the phase III ABC-02 study involving 410 patients with advanced biliary tract, gallbladder, or ampullary carcinoma, which Dr.
该结果是从一项包括了410例晚期胆管癌、胆囊或壶腹癌的患者的,称为“ABC-02”的三期试验得来的。
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