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基于生物药剂分类系统对普通口服固体制剂免除生物等效性研究的考虑 被引量：2

Considerations for biowaiver of oral immediate-release solid products based on biopharmaceutics classification system
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摘要 仿制药上市的根本条件是与原研药保持生物学等效;但是自从生物药剂分类系统(BCS)的概念提出以来,各国药品管理当局及工业界都在进行基于BCS信息免除普通口服固体制剂生物等效性研究的探索。文中介绍了不同管理当局目前所持态度,并给出具体实例,说明如何基于药物的溶解性、渗透性以及体外溶出特点,来分析是否有免除生物等效性研究的可能。
作者 张宁 平其能
机构地区 中国药科大学国际医药商学院
出处 《中国临床药理学杂志》 CAS CSCD 北大核心 2008年第4期370-372,381,共4页 The Chinese Journal of Clinical Pharmacology
关键词 生物药剂 分类系统 生物等效免除 体外溶出
分类号 R954 [医药卫生—药学] R969.1 [医药卫生—药理学]
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参考文献6

  • 1US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for industry: waiver of in vivo bioavailability and bioequivalence studies for immediate- release solid products, based on a biopharmaceutics classification system [ EB /OL ]. http://www. fda. gov/cder/guidance/3618fnl, htm,2007 - 12 - 17.
  • 2Anonymous,WHO Expert Committee on Specifications for Pharmaceutical Preparations: Fortieth Report; Annex 8: Proposal to waive in vivo bioequivalence requirements for WHO model list of essential medicines immediate- release, solid oral dosage forms [ EB /OL ]. http:// whqlibdoc, who. int/trs/WHO_TRS 937_eng. pdf,2007 - 12 - 15.
  • 3EMEA , Committee for Proprietary Medicinal Products. Note for Guidance on the investigation of bioavailability and bioequivalence [ EB/ OL]. http://www. emea. europa, eu/pdfs/human/qwp/140198enfin. pdf,2007 - 12 - 15.
  • 4Verbeeck RK,Junginger HE, Midha KK. Biowaiver monographs for immediate release solid oraldosage forms based on biopharmaceutics classificationsystem (BCS) literature data: chloroquine phosphate, chlomquine sulfate, and chloroquine hydrochloride [ J ]. J Pharm Sci, 2005 ;94:1389 -1395.
  • 5Potthas H, Dressman JB, Junginger HE. Biowaiver monographs for immediate release solid oral dosage forms: Ibuprofen [ J ]. J Pharm Sc i, 2005 ;94:2121 - 2131.
  • 6Cheng CL, Yu LX, Lee IlL. Biowaiver extension potential to BCS class Ⅲ high solubility - lowpermeability drugs: bridging evidence for metformin immediate- release tablet[ J ]. Eur J Clin Pharmacol, 2004 ;22: 294 - 304.

同被引文献15

  • 1廖洪利,吴秋业,叶光明,蔡灵芝.芒果苷药理研究进展[J].天津药学,2005,17(2):50-52. 被引量：35
  • 2罗易,朱照静.仿制药品的生物豁免[J].中国药事,2006,20(7):430-433. 被引量：4
  • 3James EP,Bertil SI,Lawrence XY,et al.Summary workshop re-port:bioequivalence,biopharmaceutics classification system,and Beyond[J].AAPS J,200;10:373-379.
  • 4Amidon GL,Lennern H,Shah VP,et al.A theoretical basisfor a biopharmaceutie drus classification:the correlation of in vitro drug product dissolution and in vivo bioavailability[J].Pharm Res,1995;12:413-420.
  • 5US Department of Health and Human Services,Food and Drug Ad-ministration,Center for Drug Evaluation and Research(CDER).Guidance for industry:waiver of in vivo bioavailability and bioequiv-alence studies for immediate-release solid products,based on a biopharmaceutics classification system[EB/OL].http://www.fda.gov/cder/guidance/3618fnl.htm,2007-12-17.
  • 6WHO Expert Committee on specifications for Pharmaceutical Prepa-rations:Fortieth Report;Annex 8.Proposal to waive in vivo bio-equivalence requirements for WHO Model List of Essential Medi-cines immediate-release,solid oral dosage forms[EB/OL].ht-tp://whqlibdoc.who.int/trs/WHO_TRS_937_eng.pdf,2008-12-15.
  • 7EMEA,Committee for Proprietary Medicinal Products.Note for guidance on the investigation of bioequivalence[EB/OL].http://www.emea.europa.eu/pdfs/human/qwp/140198enfin.pdf,2008-07-24.
  • 8国家食品药品监督管理局.药品注册管理办法[M].北京:中国法制出版社,2007:63.
  • 9梁建钦.芒果苷糖酯衍生物的非水相酶促合成及其抗炎活性研究[D].广西医科大学博士论文,2011.
  • 10张宁,平其能.生物药剂分类系统(BCS)及应用进展介绍[J].中国新药杂志,2008,17(19):1655-1658. 被引量：18

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中国临床药理学杂志
2008年 第4期

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