本文關(guān)鍵詞： 長(zhǎng)半衰期藥物 生物等效性試驗(yàn) 檢測(cè)物質(zhì) 生物等效性豁免　出處：《中國(guó)藥學(xué)雜志》2017年02期 　論文類型：期刊論文

【摘要】：目的研究FDA《特定藥物的生物等效性指導(dǎo)原則》對(duì)長(zhǎng)半衰期藥物生物等效性研究相關(guān)規(guī)定,為我國(guó)仿制藥質(zhì)量和療效一致性評(píng)價(jià)工作提供借鑒和幫助。方法針對(duì)長(zhǎng)半衰期藥物,從劑型、給藥方式、試驗(yàn)設(shè)計(jì)、受試者選擇、給藥條件、檢測(cè)物質(zhì)選擇、豁免條件、體外溶出試驗(yàn)等多個(gè)方面對(duì)FDA公布《特定藥物的生物等效性指導(dǎo)原則》進(jìn)行詳細(xì)分析,并特別指出涉及我國(guó)仿制藥質(zhì)量與療效一致性評(píng)價(jià)首批品種的長(zhǎng)半衰期藥物品種。結(jié)果 FDA公布的涉及長(zhǎng)半衰期藥物《特定藥物的生物等效性指導(dǎo)原則》對(duì)具體化學(xué)仿制藥的生物等效性評(píng)價(jià)從多個(gè)方面進(jìn)行較為詳細(xì)的規(guī)范,是對(duì)FDA相關(guān)生物等效性總則的補(bǔ)充和解讀,對(duì)仿制藥的發(fā)展有重要的推動(dòng)作用。結(jié)論在我國(guó)國(guó)家食品藥品監(jiān)督管理總局尚未頒布針對(duì)具體長(zhǎng)半衰期藥物相關(guān)生物等效性指導(dǎo)原則的背景下,FDA特定藥物的生物等效性指導(dǎo)原則中對(duì)長(zhǎng)半衰期藥物相關(guān)規(guī)范對(duì)我國(guó)正在進(jìn)行的仿制藥質(zhì)量和療效一致性評(píng)價(jià)具有一定指導(dǎo)和借鑒意義。
[Abstract]:Objective to study the guidelines for bioequivalence of specific drugs in FDA. Methods for the evaluation of quality and efficacy consistency of generic drugs in China, methods for long half-life drugs, from dosage form, method of administration, experimental design, subject selection, drug delivery conditions, detection of substance selection. Exemption conditions in vitro dissolution test and other aspects of the FDA published "guidelines for the bioequivalence of specific drugs" were analyzed in detail. In particular, it is pointed out that the long half-life drug varieties involving the consistency of quality and efficacy of the first batch of generic drugs in China are evaluated. The guidelines for Bioequivalence of specific drugs published by FDA on long Half-Life drugs have been applied to the evaluation of bioequivalence of specific chemically generic drugs from many aspects in detail. It is the supplement and interpretation of the general principles of bioequivalence related to FDA. Conclusion under the background that the State Administration of Food and Drug Administration of our country has not promulgated the guidelines for specific long half-life drug related bioequivalence. The guidelines for bioequivalence of specific drugs in FDA have a certain guiding and referential significance for the evaluation of the quality and efficacy consistency of generic drugs in China.
【作者單位】： 華北制藥股份有限公司;中國(guó)藥學(xué)會(huì);中國(guó)食品藥品檢定研究院;
【分類號(hào)】：R95
【正文快照】： 生物等效性(bioequivalence,BE)是指在相似試驗(yàn)條件下,單次或多次給予相同劑量試驗(yàn)藥物后,受試制劑中藥物的吸收速度和吸收程度與參比制劑的差異在可接受范圍內(nèi)[1]。我國(guó)正在開展的仿制藥質(zhì)量和療效一致性評(píng)價(jià)工作將生物等效性作為評(píng)價(jià)仿制藥是否通過評(píng)價(jià)的重點(diǎn)指標(biāo)。由于長(zhǎng)半，

本文編號(hào)：1443164