仿制药一致性评价中人体生物等效性试验豁免申请的进展及辅料影响考量点

廖萍,朱嘉,张景辰,吴浩,姜红

Bio-waiver in Consistency Evaluation for Generic Drugs and the Influence of Excipients

Ping LIAO,Jia ZHU,Jingchen ZHANG,Hao WU,Hong JIANG

仿制药一致性评价中BE豁免申请情况 A.维生素B6片;B.碳酸氢钠片;C.氯化钾颗粒;D.蒙脱石散;E.聚乙二醇4000散;F.对乙酰氨基酚片;G.盐酸普萘洛尔片;H.氟康唑片;I.拉米呋定片;J.盐酸尼替丁胶囊;K.异烟肼片;L.氨基葡萄糖类口服固体制剂;M.甲钴胺片;N.左乙拉西坦片

BE waiver application in conformity evaluation of generic drugs A.vitamin B6 tablets;B.sodium bicarbonate tablets;C.potassium chloride granules;D.montmorillonite powder;E.polyethylene glycol 4000 powder;F.paracetamol tablets;G.propranolol hydrochloride tablets;H.fluconazole tablets;I.lamivudine tablets;J.nitidine hydrochloride capsules;K.isoniazid tablets;L.aminoglucosamine oral solid preparation;M.mecobalamin tablets;N.levetiracetam tablets