3AMIDON GL, LENNERN H, SHAH VP, et al. A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability [ J ]. Pharm Res,1995,12(3) : 413 -420.
4US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research ( CDER). Guidance for industry: waiver of in vlvo bioavailability and bloequivalence studies for immediate-release solid products, based on a biopharmaceutics classification system[ EB/OL]. (2007 - 12 - 17). http ://www. fda. gov/cder/guidance/3618fnl.htm.
7Anonymous. 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]. (2007 - 12 - 15 ). http://whqlibdoe, who. int/trs/WHO_TRS_937_eng. pdf.
8EMEA. Committee for Proprietary Medicinal Products, Note for Guidance on the Investigation of Bioavailabitity and Bioequivalence [EB/OLJ. (2007 - 12 - 15 ). http://www. emea. europa. eu/ pdfs/human/qwF/140198enfin.pdf.
9BARENDS DM. BCS/BE in The Netherlands and Europe [ EB/ OL]. (2007 - 05 - 21 ). http ://www. aapspharmaceutica.com/ meetings/files/90/35 Barends. pdf.
