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仿制药品的生物豁免 被引量:4

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作者 罗易 朱照静
出处 《中国药事》 CAS 2006年第7期430-433,共4页 Chinese Pharmaceutical Affairs
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参考文献19

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  • 2Guidance for industry,Bioavailability and Bioequivalence Studies for Orally Administered Drug Products-General Considerations[S].2000:4
  • 3Guidance for industry:Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a Biopharmaceutics Classification System[S].2000:1
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共引文献3

同被引文献70

  • 1王晓辉.药物溶出度的测定方法及其进展[J].天津药学,2006,18(2):68-71. 被引量:22
  • 2张玉琥.对口服缓控释制剂研发中几个问题的思考[J].中国新药杂志,2007,16(1):4-7. 被引量:7
  • 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国家食品药品监督管理局.化学药物制剂人体生物利用度和生物等效性研究技术指导原则[S].2005.
  • 10U.S. Food and Drug Administration. Individual Product Bioequiv- alence Recommendations[ EB/OL]. (2011 - 01 - 11 ) . http :// wwwfdagov/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/ucm075207 htm.

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