基于生物药剂学系统分类的生物豁免的几点考虑
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摘要
基于生物药剂学系统分类(BCS)的生物豁免已在国际监管机构广为使用。我国也在2016年发布了针对仿制药一致性评价的《人体生物等效性豁免指导原则》,并在2018年5月推出了《可豁免或简化人体生物等效性试验(BE)品种名单》,提出了部分可按照BCS1类或3类豁免的品种。本文根据各国生物豁免的指南要求,分析了在国内申请BCS豁免应考虑的问题,为企业提供参考,减少不必要的BE研究和加速高质量药品的研发。
Biopharmaceutics classification system( BCS) forwaiver of in vivo bioequivalence( BE) studies has been explored widely by regulatory agencies,academia,and industry towards its implementation and further expansion. China Food and Drug Administration guidance forwaiver of in vivo bioequivalence was issued in 2016,and some BCS1 and/or BCS3 drugs were proposed in 2018. According to biowaiver guidance from international regulatory agencies,this article analyze some issues that should be considered in the biowaiver application,reducing unnecessary in vivo BE studies and speeding up availability of high quality pharmaceutical products.
Biopharmaceutics classification system( BCS) forwaiver of in vivo bioequivalence( BE) studies has been explored widely by regulatory agencies,academia,and industry towards its implementation and further expansion. China Food and Drug Administration guidance forwaiver of in vivo bioequivalence was issued in 2016,and some BCS1 and/or BCS3 drugs were proposed in 2018. According to biowaiver guidance from international regulatory agencies,this article analyze some issues that should be considered in the biowaiver application,reducing unnecessary in vivo BE studies and speeding up availability of high quality pharmaceutical products.
引文
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[3] MEHTA M U,UPPOOR R S,CONNER D P,et al. Impact of the US FDA biopharmaceutics classificationsystem(BCS)guidance on global drug development[J]. Mol Phar,2017,14(12):4334-4338.
[4] U. S. FDA. Guidance for industry:Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system[EB/OL].Rockville:FDA,2017-12-22[2018-01-04]. http://www. gmp-compliance. org/guidemgr/files/UCM070246. PDF.
[5] EMA. Guideline on investigation of bioequivalence[EB/OL]. London:EMA, 2010-01-20[2018-01-04]. http://www. ema. europa. eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039. pdf.
[6] WHO. Multisource(generic)pharmaceutical products:guidelineson registration requirements to establish interchangeability[EB/OL].Geneva:WHO,2015-12-31[2016-05-10]. http://www. who. int/medicines/areas/quality_safety/quality_assurance/Annex7-TRS992. pdf.
[7]国家食品药品监督管理总局.人体生物等效性试验豁免指导原则[EB/OL].北京:国家食品药品监督管理总局,2016-05-19[2018-01-04]. http://www. cfda. gov. cn/WS01/CL1278/153483. html.
[2] NILUFER T,HARITHA M,ZHANG H L,et al. Biopharmaceutics classification system-based biowaivers for generic oncology drug products:case studies[J]. AAPS Pharm Sci Tech,2015,16(1):5-9.
[3] MEHTA M U,UPPOOR R S,CONNER D P,et al. Impact of the US FDA biopharmaceutics classificationsystem(BCS)guidance on global drug development[J]. Mol Phar,2017,14(12):4334-4338.
[4] U. S. FDA. Guidance for industry:Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system[EB/OL].Rockville:FDA,2017-12-22[2018-01-04]. http://www. gmp-compliance. org/guidemgr/files/UCM070246. PDF.
[5] EMA. Guideline on investigation of bioequivalence[EB/OL]. London:EMA, 2010-01-20[2018-01-04]. http://www. ema. europa. eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039. pdf.
[6] WHO. Multisource(generic)pharmaceutical products:guidelineson registration requirements to establish interchangeability[EB/OL].Geneva:WHO,2015-12-31[2016-05-10]. http://www. who. int/medicines/areas/quality_safety/quality_assurance/Annex7-TRS992. pdf.
[7]国家食品药品监督管理总局.人体生物等效性试验豁免指导原则[EB/OL].北京:国家食品药品监督管理总局,2016-05-19[2018-01-04]. http://www. cfda. gov. cn/WS01/CL1278/153483. html.