[1] U.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.
[2] Rockville L. Topical bioequivalence update. U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Advisory Committee for Pharmaceutical Science Meeting[EB/OL]. [2005-05-04]. http://www.fda.gov/ohrms/dockets/ac/05/slides/2005-4137s2-Index.htm
[3] U.S. Food and Drug Administration, Title 21 Code of Federal Regulations (CFR) Part 320.1 (e), Office of Federal Register. National Archives and Records Administration[S].2009.
[4] U.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.
[5] U.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 Opportunities for Generic Drugs[EB/OL].[2007-05-01].http://www.fda.gov/oc/initiatives/criticalpath/reports/generic.html.
[6] Office of Technology Assessment, Superintendent of Documents, U.S. Government Printing Office, Washington DC 20402. Drug Bioequivalence Study Panel. Drug bioequivalence[S].1974.
[7] U.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.
[8] U.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.
[9] U.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/GuidanceComplianceRegulatoryInformation/Guidances/ucm070230.pdf
[10] U.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, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation[EB/OL]. [1995-11].http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070636.pdf.
[11] U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry: Nonsterile Semisolid Dosage Forms. Scale-Up and Post-approval Changes: Chemistry, Manufacturing and Controls, In Vitro Release Testing, and In Vivo Bioequivalence Documentation[EB/OL].[1997-05].http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070930.pdf.
[12] U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry.Dissolution Testing of Immediate Release Solid Oral Dosage Forms[EB/OL]. [1997-08].http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070237.pdf.
[13] U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry: Modified Release Solid Oral Dosage Forms. Scale-Up and Post-approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation[EB/OL]. [1997-09].http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070640.pdf.
[14] U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry: Extended Release Oral Dosage Forms: Development, Evaluation and Application of In Vitro/In Vivo Correlation[EB/OL]. [1997-09]. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070239.pdf.
[15] U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry: Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System[EB/OL]. [2000-08].http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070246.pdf.
[16] U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products-General Considerations[EB/OL]. [2003-03].http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070124.pdf.
[17] Amidon GL, Lennernäs H, Shah VP, et al. A theoretical basis for a biopharmaceutics drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability[J]. Pharm Res,1995, 12:413-420.
[18] Chen ML, Jackson AJ. The role of metabolites in bioequivalency assessment. I. Linear pharmacokinetics without first-pass effect[J]. Pharm Res, 1991, 8:25-32.
[19] Chen ML, Jackson AJ. The role of metabolites in bioequivalency assessment. I. Drugs with linear pharmacokinetics without first-pass effect[J]. Pharm Res, 1995, 12:700-708.
[20] Chen ML, Lee VHL. Equivalence-by-design: Targeting in vivo drug delivery profile[J]. Pharm Res, 2008, 25(12):2723-2708.
[21] Chen ML. Lipid excipients and delivery systems for pharmaceutical development: A regulatory perspective[J]. Adv Drug Deliv Rev, 2008,60(6):768-777.
[22] Chen ML, Straughn AB, Sadrieh N, et al. A modern view of excipient effects on bioequivalence: Case study of sorbitol[J]. Pharm Res, 2007, 24(1):73-80.
[23] Odeberg JM, Lignell A, Pettersson A, et al. Oral bioavailability of the antioxidant astaxanthin in humans is enhanced by incorporation of lipid based formulations[J]. Eur J Pharm Sci, 2003, 19(4):299-304.
[24] Basit AW, Podczeck F, Newton JM, et al. Influence of polyethylene glycol 400 on the gastrointestinal absorption of ranitidine[J]. Pharm Res, 2002,19(9):1368-1374.
[25] Yu L, Bridgers A, Polli J, et al. Vitamin E-TPGS increases absorption flux of an HIV protease inhibitor by enhancing its solubility and permeability [J]. Pharm Res, 1999, 16(12):1812-1817.
[26] Adkin DA, Davis SS, Sparrow RA, et al. The effects of pharmaceutical excipients on small intestinal transit[J]. Br J Clin Pharmac, 1995,39(4):381-387.
[27] Adkin DA, Davis SS, Sparrow RA, et al. The effect of mannitol on the oral bioavailability of cimetidine[J]. J Pharm Sci, 1995, 84(12):1405-1409.
[28] Koch KM, Parr AF, Tomlinson JJ, et al. Effect of sodium acid pyrophosphate on ranitidine bioavailability and gastrointestinal transit time[J]. Pharm Res, 1993,10(7):1027-1030.
[29] The International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use, ICH E5 Guideline, August 1998; U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry: Ethnic Factors in the Acceptability of Foreign Clinical Data[S]. Federal Register,1998, 63:31790-31796.
[30] Chen ML. Confounding factors for sex differences in pharmacokinetics and pharmacodynamics: Focus on dosing regimen, dosage form, and formulation[J]. Clin Pharmacol Ther, 2005,78:322-329.
[31] U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Center for Biologics Evaluation and Research. Guidance for Industry: Q8(R1) Pharmaceutical Development[S]. 2009. |
