期刊文献+

生物等效性和治疗等效性的现代思考

下载PDF
导出
出处 《中国临床药理学与治疗学》 CAS CSCD 2010年第6期601-606,共6页 Chinese Journal of Clinical Pharmacology and Therapeutics
  • 相关文献

参考文献32

  • 1U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Science, Office of Generic Drugs. Electronic Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations[EB/OL].[2009- 06-10]. http://www, fda. gov/cder/ob/default. htm.
  • 2Rockville L. Topical bioequivalence update. U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Advisory Committee for Pharmaceutical Science Meeting[EB/OL. [2005- 02-04]. http://www, fda. gov/ohrms/dockets/ae/ 05/slides/2005 - 4137s2-Index. htm.
  • 3U.S. Food and Drug Administration, Title 21 Code of Federal Regulations (CFR) Part 320.1 (e), Of- fice of Federal Register. National Archives and Records Administration[S]. 2009.
  • 4U.S. Food and Drug Administration, Title 21 Code of Federal Regulations (CFR) Part 320.24, Office of Federal Register. National Archives and Records Administration[S]. 2009.
  • 5U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Science, Office of Generic Drugs. Critical Path Op portunities for Generic Drugs[EB/OL]. [2007-05 01 ]. http://www, fda. gov/oc/initiatives/critical path/reports/generic, html.
  • 6Office of Technology Assessment, Superintendent of Documents, U.S. Government Printing Office, Washington DC 20402. Drug Bioequivalence Study Panel. Drug bioequivalence[S]. 1974.
  • 7U.S. Food and Drug Administration, Title 21 Code of Federal Regulations (CFR) Part 320, Office of Federal Register. National Archives and Records Administration[S]. 2009.
  • 8U.S. Food and Drug Administration, Title 21 Code of Federal Regulations (CFR) Part 320. 22, Office of Federal Register. National Archives and Records Administration[S]. 2009.
  • 9U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Generic Drugs, Division of Bioequivalence. Interim Guidance: Cholestyramine Powder - In Vitro Bioequivalence[EB/OL]. [ 1993-07]. http://www, fda. gov/ downloads/Drugs/GuidanceComplianceRegulatory-Information/ Guidances/ ucm070230. pdf.
  • 10U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry: Immediate Release Solid Oral Dosage Forms. Scale Up and Post approval Changes: Chemistry, Manufac turing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation [ EB/ OL.] [1995-11]. http://www, fda. gov/downloads/Drugs/GuidanceComplianceRegulatory Information/Guidances/ucm070636. pdf.

相关作者

内容加载中请稍等...

相关机构

内容加载中请稍等...

相关主题

内容加载中请稍等...

浏览历史

内容加载中请稍等...
;
使用帮助 返回顶部