發(fā)布時(shí)間：2018-04-22 02:19

  本文選題：CKNI數(shù)據(jù)庫 + 仿制藥��； 參考：《中國新藥雜志》2017年15期

【摘要】：2016年2月6日,國務(wù)院辦公廳印發(fā)《國務(wù)院辦公廳關(guān)于開展仿制藥質(zhì)量和療效一致性評(píng)價(jià)的意見》,提出我國將開展仿制藥質(zhì)量和療效一致性評(píng)價(jià)工作。2016年5月,CFDA發(fā)布關(guān)于落實(shí)《國務(wù)院辦公廳關(guān)于開展仿制藥質(zhì)量和療效一致性評(píng)價(jià)的意見》有關(guān)事項(xiàng)的公告,明確提出一致性評(píng)價(jià)的研究內(nèi)容之一是以參比制劑為對(duì)照,進(jìn)行固體制劑溶出曲線的比較研究。本文通過計(jì)算機(jī)檢索中國知網(wǎng)(CNKI)數(shù)據(jù)庫的方式,回顧了2013至2016年仿制藥一致性評(píng)價(jià)工作中與溶出曲線研究相關(guān)的文獻(xiàn)內(nèi)容,以期為開展一致性評(píng)價(jià)研究提供參考。
[Abstract]:In February 6, 2016, the office of the State Council issued the opinion of the office of the State Council on the evaluation of the consistency of the quality and efficacy of generic pharmaceuticals, and proposed the evaluation of the quality and efficacy of generic drugs in China in May.2016, and CFDA issued the implementation of "the agreement of the general office of the State Council on the evaluation of the consistency of the quality and efficacy of generic drugs." A comparative study of the dissolution curves of solid preparations was carried out by a comparative study of the reference preparation as a contrast. This paper reviewed the correlation of the study on the dissolution curve of the generic drug consistency evaluation from 2013 to 2016 by means of a computer retrieval method of the Chinese CNKI database. The purpose of this study is to provide references for the study of consistency evaluation.

【作者單位】： 中國食品藥品檢定研究院;
【基金】：國家“重大新藥創(chuàng)制”科技重大專項(xiàng)資助項(xiàng)目(2015ZX09303001)
【分類號(hào)】：R95

【參考文獻(xiàn)】

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本文編號(hào)：1785168