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2023-07-25

仿制藥開(kāi)發(fā)領(lǐng)域

每年申報仿制藥項目10-15個(gè)（含一致性評價(jià)）項目。已過(guò)評品種4個(gè) 已經(jīng)申報的品種17個(gè)。仿制藥開(kāi)發(fā)領(lǐng)域：

2023-07-12

磷酸奧司他韋膠囊人體生物等效性研究

用于成人和1歲及1歲以上兒童的甲型和乙型流感治療（磷酸奧司他韋能夠有效治療甲型和乙型流感，但是乙型流感的臨床應用數據尚不多）

2023-07-12

拉莫三嗪分散片人體生物等效性研究

1、癲癇；2、雙相情感障礙

2023-07-12

枸櫞酸西地那非口崩片人體生物等效性研究

用于治療勃起功能障礙

2023-07-12

非諾貝特膠囊人體生物等效性研究

供成人使用用于治療成人飲食控制療法效果不理想的高膽固醇血癥（Ⅱa 型），內源性高甘油三酯血癥，單純型（Ⅳ型）和混合型（IIb 和Ⅲ型）。特別是飲食控制后血中膽固醇仍持續升高，或是有其他并發(fā)的危險因素時(shí) 。在服藥過(guò)程中應繼續控制飲食。目前，尚無(wú)長(cháng)期臨床對照研究證明非諾貝特在動(dòng)脈粥樣硬化并發(fā)癥一級和二級預防方面的有效性。尚未證明非諾貝特能夠降低 2 型糖尿病患者的冠心病發(fā)病率和死亡。

2023-07-12

奧利司他膠囊人體生物等效性研究

用于18歲及以上成人體重超重（體重指數≥24）患者的治療。使用本產(chǎn)品，應同時(shí)配合低熱低脂飲食

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