[1] State Food and Drug Administration， Center for Drug Evaluation.Guidance for Industry：bioavailability and bioequivalence studies for chemical drug products. [EB/OL]. (2009-12-17) http：//www.cde.org.cn/zdyz.do?method=largePage&id=2066.
[2] SHAO Y. Consideration for the guideline to the generic drugs development and review to meet the revised drug registration regulation[J].Chin New Drugs J(中国新药杂志)，2008，17（15）：1283-1286.
[3] JIANG W L ，YU X Q.Review of the quality evaluation of generics in US[J].China Prescr Drug(中国处方药)，2008，79（10）：43-46.
[4] ICH Harmonised Tripartite Guideline： Pharmaceutical Development Q8(R2) [EB/OL]. (2010-03-19) http：//www.ich.org/LOB/media/MEDIA4986.pdf.
[5] JIANG W L ，YU X Q.Introduction of the evaluation of generics and summary of quality evaluation of drug sabstances in US[J]. J China Prescr Drug(中国处方药)，2008，79（10）：39-42.
[6] HUO X M . Disscussion about how to improve quality of chemical generic drugs in view of registration[J]. China Licesnsed Pharmacist（中国执业药师），2008，5(9)：36-37.
[7] WU Z. Changes of drug evaluation in the two years and trend in future [J].Chin New Drugs J(中国新药杂志)，2009，18（20）：1923-1925.
[8] US Food and Drug Administration，Critical Path Opportunities for Generic Drugs[EB/OL]. (2009-06-18) http：//www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/CriticalPathOpportunitiesReports/ucm077250.htm#quality.
[9] TGA. Australian Regulatory Guidelines for Prescription Medicines，APPENDIX 15： Biopharmaceutical Studies[EB/OL].(2010-3-30) http：//www.tga.gov.au/pmeds/argpmap15.pdf.
[10] YU L X, AMIDON G L， POLLI J E， et al.Biopharmaceutics classification system： the scientific basis for biowaiver extensions[J]. Pharm Res，2002， 19 (7)： 921-925.
[11] US Department of Health and Human Services， Food and Drug Administration， Center for Drug Evaluation and Research(CDER). Guidance for industry：Bioavailability and bioequivalence studies for orally administered drug products-General Consideration [EB/OL]. (2009-12-11) http：//www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070124.pdf.
[12] US 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]. (2008-12-17) http： //www. fda. gov/cder/guidance/3618fnl. htm.
[13] Anonymous.，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].(2008-12-15 ) http：//whqlibdoc.who.int/trs/WHO_TRS_937_eng.pdf.
[14] EMEA ，Committee for Proprietary Medicinal Products.，Note for Guidance on the Investigation of Bioequivalence[EB/OL].（2008-07-24）http：//www.emea.europa.eu/pdfs/human/qwp/140198enfin.pdf.
[15] State Food and Drug Administration， Center for Drug Evaluation.Guidance for Industry：Technical requirements for chemical generic drugs. [EB/OL]. (2009-12-17) http： //www. cde. org. cn/zdyz. do?method=largePage&id=2076.
[16] US Department of Health and Human Services， Food and Drug Administration， Center for Drug Evaluation and Research(CDER). Draft Guidance on Terconazole[EB/OL]（2009-12-27）http：//www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM199677.pdf.
[17] PERSHING L K， SLIVER B S， KRUEGER G G， et al. Feasibility of measuring the bioavailability of topical betamethasoe dipropionate in commercial formulation using drug content in skin and a skin blanching bioassay[J]. Pharm Res, 1992（9）：45-51.
[18] Ch.P (2005) Vol Ⅱ（中国药典2010 年版.二部）[S]. 2010：Appendix 7-8.
[19] ICH， Harmonised Tripartite Guideline ：Quality Overall Summary Of Module 2 Module 3 ： Quality [EB/OL].（2008-12-09）http：//www.ich.org/cache/compo/276-254-1.html.