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Dissolution testing as a prognostic tool for oral drug absorption: immediate release dosage forms. Pharm. Res.<\/i>, 15<\/b>, 11\u201322 (1998).","DOI":"10.1023\/A:1011984216775"},{"key":"2","doi-asserted-by":"crossref","unstructured":"2) Takeuchi S, Tsume Y, Amidon GE, Amidon GL. Evaluation of a three compartment in vitro<\/i> gastro intestinal simulator dissolution apparatus to predict in vivo<\/i> dissolution. J Phrma Sci.<\/i>, 103<\/b>, 3416\u20133422 (2014).","DOI":"10.1002\/jps.24112"},{"key":"3","unstructured":"3) Waterbeemd H, Lennernas H, Artursson P. Drug bioavailability estimation of solubility, permeability, absorption and bioavailability<\/i>. Wiley-VCH, Weinheim, pp. 495\u2013531 (2003)."},{"key":"4","unstructured":"4) Amidon GL, Lennern\u00e4s H, Shah VP, Crison JR. A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro<\/i> drug product dissolution and in vivo<\/i> bioavailability. Pharm. Res.<\/i>, 12<\/b>, 413\u2013420 (1995)."},{"key":"5","doi-asserted-by":"crossref","unstructured":"5) Tsume Y, Mudie DM, Langguth P, Amidon GE, Amidon GL. The biopharmaceutics classification system: subclasses for in vivo<\/i> predictive dissolution (IPD) methodology and IVIVC. Eur. J. Pharm. Sci.<\/i>, 57<\/b>, 152\u2013163 (2014).","DOI":"10.1016\/j.ejps.2014.01.009"},{"key":"6","doi-asserted-by":"crossref","unstructured":"6) Zhou L, Chen X, Gu Y, Liang J. Transport characteristics of candesartan in human intestinal Caco-2 cell line. Biopharm. Drug Dispos.<\/i>, 30<\/b>, 259\u2013264 (2009).","DOI":"10.1002\/bdd.664"},{"key":"7","doi-asserted-by":"crossref","unstructured":"7) Schwebel HJ, van Hoogevest P, Leigh ML, Kuentz M. The apparent solubilizing capacity of simulated intestinal fluids for poorly water-soluble drugs. Pharm. Dev. Technol.<\/i>, 16<\/b>, 278\u2013286 (2011).","DOI":"10.3109\/10837451003664099"},{"key":"8","doi-asserted-by":"crossref","unstructured":"8) McClellan KJ, Goa KL. Candesartan cilexetil: a review of its use in essential hypertension. Drugs<\/i>, 56<\/b>, 847\u2013869 (1998).","DOI":"10.2165\/00003495-199856050-00013"},{"key":"9","unstructured":"9) van Lier JJ, van Heiningen PN, Sunzel M. Absorption, metabolism and excretion of 14<\/sup>C-candesartan and 14<\/sup>C-candesartan cilexetil in healthy volunteers. J. Hum. Hypertens.<\/i>, 11<\/b> (Suppl. 2), S27\u2013S28 (1997)."},{"key":"10","doi-asserted-by":"crossref","unstructured":"10) Israili ZH. Clinical pharmacokinetics of angiotensin II (AT1) receptor blockers in hypertension. J. Hum. Hypertens.<\/i>, 14<\/b> (Suppl. 1), S73\u2013S86 (2000).","DOI":"10.1038\/sj.jhh.1000991"},{"key":"11","doi-asserted-by":"crossref","unstructured":"11) Teng R, Hansson AC, Borjesson I. Oral bioavailability of candesartan cilexetil suspension. J. Pharm. Technol.<\/i>, 23<\/b>, 270\u2013274 (2007).","DOI":"10.1177\/875512250702300503"},{"key":"12","doi-asserted-by":"crossref","unstructured":"12) Okumu A, DiMaso M, Lobenberg R. Dynamic dissolution testing to establish in vitro<\/i>\/in vivo<\/i> correlations for montelukast sodium, a poorly soluble drug. Pharm. Res.<\/i>, 25<\/b>, 2778\u20132785 (2008).","DOI":"10.1007\/s11095-008-9642-z"},{"key":"13","doi-asserted-by":"crossref","unstructured":"13) Paprsk\u00e1\u0159ov\u00e1 A, Mo\u017en\u00e1 P, Oga EF, Elhissi A, Alhnan MA. Instrumentation of flow-through USP IV dissolution apparatus to assess poorly soluble basic drug products: a technical note. AAPS PharmSciTech<\/i>, 17<\/b>, 1261\u20131266 (2016).","DOI":"10.1208\/s12249-015-0444-4"},{"key":"14","doi-asserted-by":"crossref","unstructured":"14) Sugano K. Introduction to computational oral absorption simulation. Expert Opin. Drug Metab. Toxicol.<\/i>, 5<\/b>, 259\u2013293 (2009).","DOI":"10.1517\/17425250902835506"},{"key":"15","doi-asserted-by":"crossref","unstructured":"15) Kaneniwa N, Watari N, Iijima H. Dissolution of slightly soluble drugs. V. Effect of particle size on gastrointestinal drug absorption and its relation to solubility. Chem. Pharm. Bull.<\/i>, 26<\/b>, 2603\u20132614 (1978).","DOI":"10.1248\/cpb.26.2603"},{"key":"16","doi-asserted-by":"crossref","unstructured":"16) Xia D, Cui F, Piao H, Cun D, Piao H, Jiang Y, Ouyang M, Quan P. Effect of crystal size on the in vitro<\/i> dissolution and oral absorption of nitrendipine in rats. Pharm. Res.<\/i>, 27<\/b>, 1965\u20131976 (2010).","DOI":"10.1007\/s11095-010-0200-0"},{"key":"17","doi-asserted-by":"crossref","unstructured":"17) Jinno J, Kamada N, Miyake M, Yamada K, Mukai T, Odomi M, Toguchi H, Liversidge GG, Higaki K, Kimura T. Effect of particle size reduction on dissolution and oral absorption of a poorly water-soluble drug, cilostazol, in beagle dogs. J. Control. Release<\/i>, 111<\/b>, 56\u201364 (2006).","DOI":"10.1016\/j.jconrel.2005.11.013"},{"key":"18","doi-asserted-by":"crossref","unstructured":"18) Jantratid E, Dressman J. Biorelevant dissolution media simulating the proximal human gastrointestinal tract: an update. Dissolut. Technol.<\/i>, 16<\/b>, 21\u201325 (2009).","DOI":"10.14227\/DT160309P21"},{"key":"19","unstructured":"19) \u201cGuideline for bioequivalence studies of generic products; English translation of attachment 1 of PSEHB\/PED notification No. 0319-1: Japan, 2020.\u201d: \u2039http:\/\/www.nihs.go.jp\/drug\/be-guide(e)\/2020\/GL1_BE_2020.pdf\u203a, accessed 24 November, 2021."},{"key":"20","unstructured":"20) \u201cThe Japanese Pharmacopeia, 18th ed.; The society of Japanese Pharmacopeia: Tokyo, Japan, 2021.\u201d: \u2039https:\/\/www.pmda.go.jp\/english\/rs-sb-std\/standards-development\/jp\/0029.html\u203a, accessed 24 November, 2021."},{"key":"21","doi-asserted-by":"crossref","unstructured":"21) Mudie DM, Amidon GL, Amidon GE. Physiological parameters for oral delivery and in vitro<\/i> testing. Mol. Pharm.<\/i>, 7<\/b>, 1388\u20131405 (2010).","DOI":"10.1021\/mp100149j"},{"key":"22","doi-asserted-by":"crossref","unstructured":"22) Fuchs A, Leigh M, Kloefer B, Dressman JB. Advances in the design of fasted state simulating intestinal fluids: FaSSIF-V3. Eur. J. Pharm. Biopharm.<\/i>, 94<\/b>, 229\u2013240 (2015).","DOI":"10.1016\/j.ejpb.2015.05.015"},{"key":"23","doi-asserted-by":"crossref","unstructured":"23) Xie X, Cardot JM, Garrait G, Thery V, El-Hajji M, Beyssac E. Micelle dynamic simulation and physicochemical characterization of biorelevant media to reflect gastrointestinal environment in fasted and fed states. Eur. J. Pharm. Biopharm.<\/i>, 88<\/b>, 565\u2013573 (2014).","DOI":"10.1016\/j.ejpb.2014.05.020"},{"key":"24","doi-asserted-by":"crossref","unstructured":"24) Davis SS, Hardy JG, Fara JW. Transit of pharmaceutical dosage forms through the small intestine. Gut<\/i>, 27<\/b>, 886\u2013892 (1986).","DOI":"10.1136\/gut.27.8.886"},{"key":"25","doi-asserted-by":"crossref","unstructured":"25) Sugano K. Possible reduction of effective thickness of intestinal unstirred water layer by particle drifting effect. Int. J. Pharm.<\/i>, 387<\/b>, 103\u2013109 (2010).","DOI":"10.1016\/j.ijpharm.2009.12.014"},{"key":"26","doi-asserted-by":"crossref","unstructured":"26) Ponchel G, Irache J. Specific and non-specific bioadhesive particulate systems for oral delivery to the gastrointestinal tract. Adv. Drug Deliv. Rev.<\/i>, 34<\/b>, 191\u2013219 (1998).","DOI":"10.1016\/S0169-409X(98)00040-4"},{"key":"27","doi-asserted-by":"crossref","unstructured":"27) Ohashi R, Kamikozawa Y, Sugiura M, Fukuda H, Yabuuchi H, Tamai I. Effect of P-glycoprotein on intestinal absorption and brain penetration of antiallergic agent bepotastine besilate. Drug Metab. Dispos.<\/i>, 34<\/b>, 793\u2013799 (2006).","DOI":"10.1124\/dmd.105.007559"},{"key":"28","unstructured":"28) Pharmaceuticals and Medical Devices Agency. \u201cIF of Candesartan \u201cSawai\u201d: Japan, 2020.\u201d: \u2039https:\/\/www.info.pmda.go.jp\/go\/interview\/1\/300119_2149040F5048_1_061_1F.pdf\u203a, accessed 24 November, 2021."},{"key":"29","unstructured":"29) Matsuguma K, Tao I, Kato T, Kiwata S, Ueno S, Ohnishi A. Bioequivalence study of candesartan tablets 2\u2009mg \u201cSawai\u201d, candesartan tablets 4\u2009mg \u201cSawai\u201d, candesartan tablets 8\u2009mg \u201cSawai\u201d and candesartan tablets 12\u2009mg \u201cSawai\u201d in healthy subjects. Medical Consultation & New Remedies<\/i>, 51<\/b>, 959\u2013971 (2014)."}],"container-title":["Biological and Pharmaceutical Bulletin"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.jstage.jst.go.jp\/article\/bpb\/45\/3\/45_b21-01029\/_pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,3,5]],"date-time":"2022-03-05T04:17:20Z","timestamp":1646453840000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.jstage.jst.go.jp\/article\/bpb\/45\/3\/45_b21-01029\/_article"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,3,1]]},"references-count":29,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2022]]}},"URL":"https:\/\/doi.org\/10.1248\/bpb.b21-01029","relation":{},"ISSN":["0918-6158","1347-5215"],"issn-type":[{"value":"0918-6158","type":"print"},{"value":"1347-5215","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,3,1]]},"article-number":"b21-01029"}}