| [1] |
Anand O,Lawrence XY,Conner DP,et al.Dissolution testing for generic drugs:an FDA perspective[J].AAPS J,2011,13(3):328.
|
| [2] |
Tsume Y,Matsui K,Searls AL,et al.The impact of supersaturation level for oral absorption of BCS class IIb drugs,dipyridamole and ketoconazole,using in vivo predictive dissolution system:gastrointestinal simulator(GIS)[J].Eur J Pharm Sci,2017,102(5):126-139.
|
| [3] |
Li ZQ,He X,Liu CX.Recent advances in drug dissolution/permeation synchronous evaluation technologies based on physiological characteristics of gastrointestinal tract [J].Acta Pharm Sin(药学学报),2016,51(10):1540-1550.
|
| [4] |
U. S. Food and Drug Administration. Guidance for industry,extended release oral dosage forms:development,evaluation,and application of in vitro/in vivo correlations[EB/OL].(1997-09)[2017-11-13] .https://www.fda.gov/downloads/dru-gs/guidAncecomplianceregulatoryinformation/guidances/ucm070239.pdf.
|
| [5] |
Gite S,Chogale M,Patravale V.Development and validation of a discriminating dissolution method for atorvastatin delayed-release nanoparticles using a flow through cell:a comparative study using USP apparatus 4 and 1[J].Dissolut Technol,2016,23(2):14-20.
|
| [6] |
Prajapat MD,Patel NJ,Bariya A,et al.Formulation and evaluation of self-emulsifying drug delivery system for nimodipine,a BCS class II drug[J].J Drug Deliv Sci Tec,2017,39(6):59-68.
|
| [7] |
Margolskee A,Darwich AS,Galetin A,et al.Deconvolution and IVIVC:exploring the role of rate-limiting conditions[J].AAPS J,2016,18(2):321-332.
|
| [8] |
Hardikar S, Bhosale AV, Budhawant RN. Establishment of in vivo-in vitro correlation:a cogent strategy in product development process[J].Indian J Pharm Edu,2014,48(4):66-73.
|
| [9] |
Tsume Y, Mudie DM, Langguth P, et al. The Biopharmaceutics classification system:subclasses for in vivo predictive dissolution(IPD)methodology and IVIVC[J].Eur J Pharm Sci,2014,57(1):152-163.
|
| [10] |
Kumar V,Lalit Kumar K,Shavej A,et al.Application of assumed IVIVC in product life cycle management:a case study of trimetazidine dihydrochloride extended release tablet[J].J Bioequiv Availab,2013,5(1):006-015.
|
| [11] |
Suarez-Sharp S,Li M,Duan J,et al.Regulatory experience with in vivo in vitro correlations(IVIVC)in new drug applications[J].AAPS J,2016,18(6):1379-1390.
|
| [12] |
Rämsch KD,Graefe KH,Scherling D,et al.Pharmacokinetics and metabolism of calcium-blocking agents nifedipine,nitrendipine,and nimodipine[J].Am J Nephrol,1986,6(Suppl 1):73-80.
|
| [13] |
Gualano V,Ntsikoussalabongui B,Mignot A,et al.Comparative bioavailability of two oral nimodipine formulations after administration to 24 healthy volunteers[J].Clin Drug Invest,1999,17(6):475-482.
|
| [14] |
Serban C,Sahebkar A,Ursoniu S,et al.A systematic review and meta-analysis of the effect of statins on plasma asymmetric dimethylarginine concentrations[J].Sci Rep,2015,5(1):9902.
|
| [15] |
González-García I,Mangas-Sanjuán V,Merino-Sanjuán M,et al.In vitro-in vivo correlations:general concepts,methodologies and regulatory applications[J].Drug Dev Ind Pharm,2015,41(12):1935-1947.
|
| [16] |
Liu J,Ma MC,Chow SC.Statistical evaluation of similarity factor f2 as a criterion for assessment of similarity between dissolution profiles[J].Drug Inf J,1997,31(4):1255-1271.
|
| [17] |
Shah VP,Tsong Y,Sathe P,et al.In vitro dissolution profile comparison-statistics and analysis of the similarity factor,f2[J].Pharm Res,1998,15(6):889-896.
|
| [18] |
Tsong Y,Hammerstrom T,Sathe P,et al.Statistical assessment of mean differences between two dissolution data sets[J].Ther Innov Regul Sci,1996,30(4):1105-1112.
|
| [19] |
Zhang Y,Huo M,Zhou J,et al.DDSolver:an add-in program for modeling and comparison of drug dissolution profiles[J].AAPS J,2010,12(3):263-271.
|
| [20] |
Chinese Pharmacopoeia Commission.Chinese Pharmacopoeia:part 2(中华人民共和国药典:二部)[S].Beijing:China Medical Science Press,2015:309-310.
|
| [21] |
U.S.Food and Drug Administration.Guidance for industry.dissolution testing of immediate release solid oral dosage forms[EB/OL].https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070237.pdf.
|
| [22] |
Cascone S,Lamberti G,Marra F,et al.Gastrointestinal behavior and ADME phenomena:I.In vitro simulation[J].J Drug Deliv Sci Technol,2016,35(5):272-283.
|
| [23] |
Xie MF.An understanding of "the quality consistency evaluation technique for oral solid pharmaceutical preparation"-multiple dissolution curves[J].Chin J Drug Eval(中国药物评价),2013,30(2):65-66.
|
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