{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T19:21:47Z","timestamp":1792783307543,"version":"4.5.0"},"reference-count":113,"publisher":"Springer Science and Business Media LLC","license":[{"start":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T00:00:00Z","timestamp":1791849600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T00:00:00Z","timestamp":1791849600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"National Research Foundation of Korea","award":["RS-2024-00348330"],"award-info":[{"award-number":["RS-2024-00348330"]}],"id":[{"id":"https:\/\/ror.org\/013aysd81","id-type":"ROR","asserted-by":"crossref"}]},{"name":"Ministry of Trade, Industry and Resources","award":["RS-2025-13312968"],"award-info":[{"award-number":["RS-2025-13312968"]}],"id":[{"id":"https:\/\/ror.org\/02jfryy43","id-type":"ROR","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Arch. Pharm. Res."],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>In vitro\u2013in vivo correlation (IVIVC) links in vitro dissolution to in vivo drug exposure, enabling the prediction of systemic pharmacokinetics and supporting formulation optimization, dissolution specification setting, and regulatory biowaivers for modified-release dosage forms. Its classical success relies on the assumption that the in vitro release profile remains the dominant surrogate of the in vivo input function, enabling point-to-point Level A relationships between the dissolved and absorbed fractions. This paradigm remains effective in dissolution-controlled systems, where formulation-dependent release rate differences reliably predict in vivo input rates. However, conventional IVIVC breaks down when systemic exposure is governed by drug-specific absorption properties, formulation-dependent post-dissolution phase behavior, physiology-sensitive luminal variability, or inherently complex multi-process release systems. This review proposes a conceptual framework that organizes these previously recognized challenges into four categories: absorption process\u2013driven, formulation-driven, physiological variability\u2013driven, and complex release\u2013driven. The categories may coexist in a single product, and each is linked to modeling strategies reported to improve predictive performance. Physiologically based biopharmaceutics modeling, population pharmacokinetic-based IVIVC, and convolution-based approaches are examined in terms of how each explicitly separates dissolution from absorption. The three differ in how directly they represent the underlying biological and physicochemical processes. Particular emphasis is placed on how these strategies support model-informed dissolution specification setting, virtual bioequivalence assessment, and prospective formulation design within the verified domain of each model.<\/jats:p>","DOI":"10.1007\/s12272-026-01642-9","type":"journal-article","created":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T03:50:17Z","timestamp":1791863417000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Mechanism-based classification of in vitro\u2013in vivo correlation failures and model-informed strategies for drug product development"],"prefix":"10.1007","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8328-1087","authenticated-orcid":false,"given":"Soyoung","family":"Shin","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6706-5445","authenticated-orcid":false,"given":"Beom Soo","family":"Shin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,10,13]]},"reference":[{"key":"1642_CR1","doi-asserted-by":"publisher","first-page":"1782","DOI":"10.1007\/s11095-016-1917-1","volume":"33","author":"AY Abuhelwa","year":"2016","unstructured":"Abuhelwa AY, Mudge S, Hayes D, Upton RN, Foster DJ (2016) Population in vitro-in vivo correlation model linking gastrointestinal transit time, pH, and pharmacokinetics: itraconazole as a model drug. Pharm Res 33:1782\u20131794. https:\/\/doi.org\/10.1007\/s11095-016-1917-1","journal-title":"Pharm Res"},{"issue":"Suppl 1","key":"1642_CR2","doi-asserted-by":"publisher","first-page":"S41","DOI":"10.1016\/s0169-409x(01)00179-x","volume":"50","author":"B Agoram","year":"2001","unstructured":"Agoram B, Woltosz WS, Bolger MB (2001) Predicting the impact of physiological and biochemical processes on oral drug bioavailability. Adv Drug Deliv Rev 50(Suppl 1):S41-67. https:\/\/doi.org\/10.1016\/s0169-409x(01)00179-x","journal-title":"Adv Drug Deliv Rev"},{"key":"1642_CR3","doi-asserted-by":"publisher","first-page":"413","DOI":"10.1023\/a:1016212804288","volume":"12","author":"GL Amidon","year":"1995","unstructured":"Amidon GL, Lennernas H, Shah VP, Crison JR (1995) A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm Res 12:413\u2013420. https:\/\/doi.org\/10.1023\/a:1016212804288","journal-title":"Pharm Res"},{"key":"1642_CR4","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1016\/j.jconrel.2019.07.013","volume":"308","author":"JV Andhariya","year":"2019","unstructured":"Andhariya JV, Jog R, Shen J, Choi S, Wang Y, Zou Y, Burgess DJ (2019) Development of level A in vitro-in vivo correlations for peptide loaded PLGA microspheres. J Control Release 308:1\u201313. https:\/\/doi.org\/10.1016\/j.jconrel.2019.07.013","journal-title":"J Control Release"},{"key":"1642_CR5","doi-asserted-by":"publisher","first-page":"193","DOI":"10.1016\/j.ejpb.2016.06.010","volume":"105","author":"CJ Andreas","year":"2016","unstructured":"Andreas CJ, Tomaszewska I, Muenster U, van der Mey D, Mueck W, Dressman JB (2016) Can dosage form-dependent food effects be predicted using biorelevant dissolution tests? Case example extended release nifedipine. Eur J Pharm Biopharm 105:193\u2013202. https:\/\/doi.org\/10.1016\/j.ejpb.2016.06.010","journal-title":"Eur J Pharm Biopharm"},{"key":"1642_CR6","doi-asserted-by":"publisher","first-page":"2735","DOI":"10.1021\/acs.molpharmaceut.5c00225","volume":"22","author":"S Arora","year":"2025","unstructured":"Arora S, Pepin X, Jamei M, Sharma P, Heimbach T, Wagner C, Bransford P, Kollipara S, Ahmed T, Hingle M, Dallmann A, Scherholz M, Stamatis SD, Cano-Vega M, Mistry N, Tannergren C, Borges L, Lindahl A, Rullo G, Mackie C, Mitra A, Kushner J, Harish Jain KM, Polli JE (2025) Development of a physiologically based biopharmaceutics model report template: considerations for improved quality in view of regulatory submissions. Mol Pharm 22:2735\u20132746. https:\/\/doi.org\/10.1021\/acs.molpharmaceut.5c00225","journal-title":"Mol Pharm"},{"key":"1642_CR7","doi-asserted-by":"publisher","first-page":"1176","DOI":"10.1002\/jps.1071","volume":"90","author":"G Balan","year":"2001","unstructured":"Balan G, Timmins P, Greene DS, Marathe PH (2001) In vitro-in vivo correlation (IVIVC) models for metformin after administration of modified-release (MR) oral dosage forms to healthy human volunteers. J Pharm Sci 90:1176\u20131185. https:\/\/doi.org\/10.1002\/jps.1071","journal-title":"J Pharm Sci"},{"key":"1642_CR8","doi-asserted-by":"publisher","DOI":"10.3390\/pharmaceutics12010074","volume":"12","author":"M Bermejo","year":"2020","unstructured":"Bermejo M, Hens B, Dickens J, Mudie D, Paixao P, Tsume Y, Shedden K, Amidon GL (2020) A mechanistic physiologically-based biopharmaceutics modeling (PBBM) approach to assess the in vivo performance of an orally administered drug product: from IVIVC to IVIVP. Pharmaceutics 12:74. https:\/\/doi.org\/10.3390\/pharmaceutics12010074","journal-title":"Pharmaceutics"},{"key":"1642_CR9","doi-asserted-by":"publisher","first-page":"25","DOI":"10.1016\/j.ijpharm.2012.11.026","volume":"453","author":"J Bevernage","year":"2013","unstructured":"Bevernage J, Brouwers J, Brewster ME, Augustijns P (2013) Evaluation of gastrointestinal drug supersaturation and precipitation: strategies and issues. Int J Pharm 453:25\u201335. https:\/\/doi.org\/10.1016\/j.ijpharm.2012.11.026","journal-title":"Int J Pharm"},{"key":"1642_CR10","doi-asserted-by":"publisher","first-page":"193","DOI":"10.1208\/s12249-024-02904-9","volume":"25","author":"AK Bhattiprolu","year":"2024","unstructured":"Bhattiprolu AK, Kollipara S, Boddu R, Arumugam A, Khan SM, Ahmed T (2024) A semi-mechanistic physiologically based biopharmaceutics model to describe complex and saturable absorption of metformin: justification of dissolution specifications for extended release formulation. AAPS PharmSciTech 25:193. https:\/\/doi.org\/10.1208\/s12249-024-02904-9","journal-title":"AAPS PharmSciTech"},{"key":"1642_CR11","doi-asserted-by":"publisher","DOI":"10.1208\/s12249-024-03006-2","volume":"26","author":"F Bi","year":"2024","unstructured":"Bi F, Yuan T, Zhang B, Li J, Lin Y, Yang J (2024) Establishment of biopredictive dissolution and bioequivalence safe space using the physiologically based biopharmaceutics modeling for tacrolimus extended-release capsules. AAPS PharmSciTech 26:13. https:\/\/doi.org\/10.1208\/s12249-024-03006-2","journal-title":"AAPS PharmSciTech"},{"key":"1642_CR12","doi-asserted-by":"publisher","DOI":"10.3390\/pharmaceutics17101310","volume":"17","author":"A Bourderi-Cambon","year":"2025","unstructured":"Bourderi-Cambon A, Fadhlaoui K, Garrait G, Laine E, Dhifallah I, Rossano M, Caisse P, Beyssac E (2025) Improving in vitro-in vivo correlation (IVIVC) for lipid-based formulations: overcoming challenges and exploring opportunities. Pharmaceutics 17:1310. https:\/\/doi.org\/10.3390\/pharmaceutics17101310","journal-title":"Pharmaceutics"},{"key":"1642_CR13","doi-asserted-by":"publisher","first-page":"2549","DOI":"10.1002\/jps.21650","volume":"98","author":"J Brouwers","year":"2009","unstructured":"Brouwers J, Brewster ME, Augustijns P (2009) Supersaturating drug delivery systems: the answer to solubility-limited oral bioavailability? J Pharm Sci 98:2549\u20132572. https:\/\/doi.org\/10.1002\/jps.21650","journal-title":"J Pharm Sci"},{"key":"1642_CR14","doi-asserted-by":"publisher","first-page":"201","DOI":"10.1208\/s12248-011-9257-x","volume":"13","author":"JB Bulitta","year":"2011","unstructured":"Bulitta JB, Bingolbali A, Shin BS, Landersdorfer CB (2011) Development of a new pre- and post-processing tool (SADAPT-TRAN) for nonlinear mixed-effects modeling in S-ADAPT. AAPS J 13:201\u2013211. https:\/\/doi.org\/10.1208\/s12248-011-9257-x","journal-title":"AAPS J"},{"key":"1642_CR15","doi-asserted-by":"publisher","first-page":"491","DOI":"10.1208\/s12248-012-9359-0","volume":"14","author":"JM Cardot","year":"2012","unstructured":"Cardot JM, Davit BM (2012) In vitro-in vivo correlations: tricks and traps. AAPS J 14:491\u2013499. https:\/\/doi.org\/10.1208\/s12248-012-9359-0","journal-title":"AAPS J"},{"key":"1642_CR16","doi-asserted-by":"publisher","DOI":"10.1007\/s40005-026-00805-6","author":"N Choi","year":"2026","unstructured":"Choi N, Shin BS, Shin S (2026) Evolution of human pharmacokinetics prediction methods: from allometry to artificial intelligence. J Pharm Investig. https:\/\/doi.org\/10.1007\/s40005-026-00805-6","journal-title":"J Pharm Investig"},{"key":"1642_CR17","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1093\/toxsci\/kfac101","volume":"191","author":"WC Chou","year":"2023","unstructured":"Chou WC, Lin Z (2023) Machine learning and artificial intelligence in physiologically based pharmacokinetic modeling. Toxicol Sci 191:1\u201314. https:\/\/doi.org\/10.1093\/toxsci\/kfac101","journal-title":"Toxicol Sci"},{"key":"1642_CR18","doi-asserted-by":"publisher","first-page":"519","DOI":"10.1007\/s10928-011-9206-4","volume":"38","author":"C Costello","year":"2011","unstructured":"Costello C, Rossenu S, Vermeulen A, Cleton A, Dunne A (2011) A time scaling approach to develop an in vitro-in vivo correlation (IVIVC) model using a convolution-based technique. J Pharmacokinet Pharmacodyn 38:519\u2013539. https:\/\/doi.org\/10.1007\/s10928-011-9206-4","journal-title":"J Pharmacokinet Pharmacodyn"},{"key":"1642_CR19","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijpharm.2020.119210","volume":"580","author":"MG Davanco","year":"2020","unstructured":"Davanco MG, Campos DR, Carvalho PO (2020) In vitro - in vivo correlation in the development of oral drug formulation: a screenshot of the last two decades. Int J Pharm 580:119210. https:\/\/doi.org\/10.1016\/j.ijpharm.2020.119210","journal-title":"Int J Pharm"},{"key":"1642_CR20","doi-asserted-by":"publisher","first-page":"76","DOI":"10.1016\/j.jconrel.2008.04.005","volume":"129","author":"A Dokoumetzidis","year":"2008","unstructured":"Dokoumetzidis A, Macheras P (2008) IVIVC of controlled release formulations: physiological-dynamical reasons for their failure. J Control Release 129:76\u201378. https:\/\/doi.org\/10.1016\/j.jconrel.2008.04.005","journal-title":"J Control Release"},{"issue":"Suppl 2","key":"1642_CR21","doi-asserted-by":"publisher","first-page":"S73","DOI":"10.1016\/s0928-0987(00)00181-0","volume":"11","author":"JB Dressman","year":"2000","unstructured":"Dressman JB, Reppas C (2000) In vitro-in vivo correlations for lipophilic, poorly water-soluble drugs. Eur J Pharm Sci 11(Suppl 2):S73-80. https:\/\/doi.org\/10.1016\/s0928-0987(00)00181-0","journal-title":"Eur J Pharm Sci"},{"key":"1642_CR22","doi-asserted-by":"publisher","first-page":"11","DOI":"10.1023\/a:1011984216775","volume":"15","author":"JB Dressman","year":"1998","unstructured":"Dressman JB, Amidon GL, Reppas C, Shah VP (1998) Dissolution testing as a prognostic tool for oral drug absorption: immediate release dosage forms. Pharm Res 15:11\u201322. https:\/\/doi.org\/10.1023\/a:1011984216775","journal-title":"Pharm Res"},{"key":"1642_CR23","doi-asserted-by":"publisher","first-page":"1949","DOI":"10.1002\/jps.20387","volume":"94","author":"S Dutta","year":"2005","unstructured":"Dutta S, Qiu Y, Samara E, Cao G, Granneman GR (2005) Once-a-day extended-release dosage form of divalproex sodium III: development and validation of a Level A in vitro-in vivo correlation (IVIVC). J Pharm Sci 94:1949\u20131956. https:\/\/doi.org\/10.1002\/jps.20387","journal-title":"J Pharm Sci"},{"key":"1642_CR24","first-page":"169","volume":"9","author":"J Emami","year":"2006","unstructured":"Emami J (2006) In vitro - in vivo correlation: from theory to applications. J Pharm Pharm Sci 9:169\u2013189","journal-title":"J Pharm Pharm Sci"},{"key":"1642_CR25","first-page":"183","volume":"46","author":"J Fallingborg","year":"1999","unstructured":"Fallingborg J (1999) Intraluminal pH of the human gastrointestinal tract. Dan Med Bull 46:183\u2013196","journal-title":"Dan Med Bull"},{"key":"1642_CR26","doi-asserted-by":"publisher","first-page":"1274","DOI":"10.1016\/j.ejpb.2013.03.001","volume":"85","author":"Y Fei","year":"2013","unstructured":"Fei Y, Kostewicz ES, Sheu MT, Dressman JB (2013) Analysis of the enhanced oral bioavailability of fenofibrate lipid formulations in fasted humans using an in vitro-in silico-in vivo approach. Eur J Pharm Biopharm 85:1274\u20131284. https:\/\/doi.org\/10.1016\/j.ejpb.2013.03.001","journal-title":"Eur J Pharm Biopharm"},{"key":"1642_CR27","doi-asserted-by":"publisher","first-page":"191","DOI":"10.1007\/s11095-012-0862-x","volume":"30","author":"J Fourie Zirkelbach","year":"2013","unstructured":"Fourie Zirkelbach J, Jackson AJ, Wang Y, Schuirmann DJ (2013) Use of partial AUC (PAUC) to evaluate bioequivalence\u2013a case study with complex absorption: methylphenidate. Pharm Res 30:191\u2013202. https:\/\/doi.org\/10.1007\/s11095-012-0862-x","journal-title":"Pharm Res"},{"key":"1642_CR28","doi-asserted-by":"publisher","first-page":"1946","DOI":"10.1248\/bpb.31.1946","volume":"31","author":"A Ghosh","year":"2008","unstructured":"Ghosh A, Bhaumik UK, Bose A, Mandal U, Gowda V, Chatterjee B, Chakrabarty US, Pal TK (2008) Extended release dosage form of glipizide: development and validation of a level A in vitro-in vivo correlation. Biol Pharm Bull 31:1946\u20131951. https:\/\/doi.org\/10.1248\/bpb.31.1946","journal-title":"Biol Pharm Bull"},{"key":"1642_CR29","doi-asserted-by":"publisher","first-page":"53","DOI":"10.1007\/978-1-4684-6036-0_5","volume":"423","author":"WR Gillespie","year":"1997","unstructured":"Gillespie WR (1997) Convolution-based approaches for in vivo-in vitro correlation modeling. Adv Exp Med Biol 423:53\u201365. https:\/\/doi.org\/10.1007\/978-1-4684-6036-0_5","journal-title":"Adv Exp Med Biol"},{"key":"1642_CR30","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijpharm.2023.123267","volume":"643","author":"A Golhar","year":"2023","unstructured":"Golhar A, Pillai M, Dhakne P, Rajput N, Jadav T, Sengupta P (2023) Progressive tools and critical strategies for development of best fit PBPK model aiming better in vitro-in vivo correlation. Int J Pharm 643:123267. https:\/\/doi.org\/10.1016\/j.ijpharm.2023.123267","journal-title":"Int J Pharm"},{"key":"1642_CR31","doi-asserted-by":"publisher","first-page":"67","DOI":"10.1208\/s12248-020-00445-0","volume":"22","author":"R Gomeni","year":"2020","unstructured":"Gomeni R, Bressolle-Gomeni F (2020) Comparison of alternative population modeling approaches for implementing a level A IVIVC and for assessing the time-scaling factor using deconvolution and convolution-based methods. AAPS J 22:67. https:\/\/doi.org\/10.1208\/s12248-020-00445-0","journal-title":"AAPS J"},{"key":"1642_CR32","doi-asserted-by":"publisher","first-page":"1935","DOI":"10.3109\/03639045.2015.1054833","volume":"41","author":"I Gonzalez-Garcia","year":"2015","unstructured":"Gonzalez-Garcia I, Mangas-Sanjuan V, Merino-Sanjuan M, Bermejo M (2015) In vitro-in vivo correlations: general concepts, methodologies and regulatory applications. Drug Dev Ind Pharm 41:1935\u20131947. https:\/\/doi.org\/10.3109\/03639045.2015.1054833","journal-title":"Drug Dev Ind Pharm"},{"key":"1642_CR33","doi-asserted-by":"publisher","first-page":"132","DOI":"10.1002\/psp4.13067","volume":"13","author":"PK Gupta","year":"2024","unstructured":"Gupta PK, Incledon B, Gobburu JVS, Gomeni R (2024) A convolution-based in vitro-in vivo correlation model for methylphenidate hydrochloride delayed-release and extended-release capsule. CPT Pharmacometrics Syst Pharmacol 13:132\u2013142. https:\/\/doi.org\/10.1002\/psp4.13067","journal-title":"CPT Pharmacometrics Syst Pharmacol"},{"key":"1642_CR34","doi-asserted-by":"publisher","first-page":"105","DOI":"10.1016\/j.ejpb.2010.05.006","volume":"76","author":"U Heigoldt","year":"2010","unstructured":"Heigoldt U, Sommer F, Daniels R, Wagner KG (2010) Predicting in vivo absorption behavior of oral modified release dosage forms containing pH-dependent poorly soluble drugs using a novel pH-adjusted biphasic in vitro dissolution test. Eur J Pharm Biopharm 76:105\u2013111. https:\/\/doi.org\/10.1016\/j.ejpb.2010.05.006","journal-title":"Eur J Pharm Biopharm"},{"key":"1642_CR35","doi-asserted-by":"publisher","first-page":"5353","DOI":"10.1021\/acs.molpharmaceut.4c00758","volume":"21","author":"T Heimbach","year":"2024","unstructured":"Heimbach T, Musuamba Tshinanu F, Raines K, Borges L, Kijima S, Malamatari M, Moody R, Veerasingham S, Seo P, Turner D, Fang L, Stillhart C, Bransford P, Ren X, Patel N, Sperry D, Chen H, Rostami-Hodjegan A, Lukacova V, Sun D, Nguefack JF, Carducci T, Grimstein M, Pepin X, Jamei M, Stamatopoulos K, Li M, Sanghavi M, Tannergren C, Mandula H, Zhao Z, Ju TR, Wagner C, Arora S, Wang M, Rullo G, Mitra A, Kollipara S, Chirumamilla SK, Polli JE, Mackie C (2024) PBBM considerations for base models, model validation, and application steps: workshop summary report. Mol Pharm 21:5353\u20135372. https:\/\/doi.org\/10.1021\/acs.molpharmaceut.4c00758","journal-title":"Mol Pharm"},{"key":"1642_CR36","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejps.2022.106166","volume":"174","author":"FL Holzem","year":"2022","unstructured":"Holzem FL, Schaffland JP, Brandl M, Bauer-Brandl A, Stillhart C (2022) Microdialysis and nanofiltration allow to distinguish molecularly dissolved from colloid-associated drug concentrations during biomimetic dissolution testing of supersaturating formulations. Eur J Pharm Sci 174:106166. https:\/\/doi.org\/10.1016\/j.ejps.2022.106166","journal-title":"Eur J Pharm Sci"},{"key":"1642_CR37","doi-asserted-by":"publisher","first-page":"3054","DOI":"10.1016\/j.xphs.2024.07.017","volume":"113","author":"FL Holzem","year":"2024","unstructured":"Holzem FL, Parrott N, Petrig Schaffland J, Brandl M, Bauer-Brandl A, Stillhart C (2024b) Oral absorption from surfactant-based drug formulations: the impact of molecularly dissolved drug on bioavailability. J Pharm Sci 113:3054\u20133064. https:\/\/doi.org\/10.1016\/j.xphs.2024.07.017","journal-title":"J Pharm Sci"},{"key":"1642_CR38","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejps.2024.106703","volume":"194","author":"FL Holzem","year":"2024","unstructured":"Holzem FL, Petrig Schaffland J, Brandl M, Bauer-Brandl A, Stillhart C (2024a) Using molecularly dissolved drug concentrations in PBBMs improves the prediction of oral absorption from supersaturating formulations. Eur J Pharm Sci 194:106703. https:\/\/doi.org\/10.1016\/j.ejps.2024.106703","journal-title":"Eur J Pharm Sci"},{"key":"1642_CR39","doi-asserted-by":"publisher","first-page":"2469","DOI":"10.1016\/j.apsb.2021.03.025","volume":"11","author":"Y Huang","year":"2021","unstructured":"Huang Y, Yu Q, Chen Z, Wu W, Zhu Q, Lu Y (2021) In vitro and in vivo correlation for lipid-based formulations: current status and future perspectives. Acta Pharm Sin B 11:2469\u20132487. https:\/\/doi.org\/10.1016\/j.apsb.2021.03.025","journal-title":"Acta Pharm Sin B"},{"key":"1642_CR40","doi-asserted-by":"publisher","first-page":"1167","DOI":"10.1023\/a:1015988410977","volume":"7","author":"Z Hussein","year":"1990","unstructured":"Hussein Z, Friedman M (1990) Release and absorption characteristics of novel theophylline sustained-release formulations: in vitro-in vivo correlation. Pharm Res 7:1167\u20131171. https:\/\/doi.org\/10.1023\/a:1015988410977","journal-title":"Pharm Res"},{"key":"1642_CR41","doi-asserted-by":"publisher","first-page":"966","DOI":"10.1002\/cpdd.1089","volume":"11","author":"B Incledon","year":"2022","unstructured":"Incledon B, Incledon C, Gomeni R, Uchida CL, Morris A, Perry K, Kapuscinski J (2022) Effect of colonic absorption on the pharmacokinetic properties of delayed-release and extended-release methylphenidate. In vivo, in vitro, and modeling evaluations. Clin Pharmacol Drug Dev 11:966\u2013975. https:\/\/doi.org\/10.1002\/cpdd.1089","journal-title":"Clin Pharmacol Drug Dev"},{"key":"1642_CR42","doi-asserted-by":"publisher","first-page":"225","DOI":"10.1208\/s12248-009-9099-y","volume":"11","author":"M Jamei","year":"2009","unstructured":"Jamei M, Turner D, Yang J, Neuhoff S, Polak S, Rostami-Hodjegan A, Tucker G (2009) Population-based mechanistic prediction of oral drug absorption. AAPS J 11:225\u2013237. https:\/\/doi.org\/10.1208\/s12248-009-9099-y","journal-title":"AAPS J"},{"key":"1642_CR43","doi-asserted-by":"publisher","first-page":"1663","DOI":"10.1007\/s11095-008-9569-4","volume":"25","author":"E Jantratid","year":"2008","unstructured":"Jantratid E, Janssen N, Reppas C, Dressman JB (2008) Dissolution media simulating conditions in the proximal human gastrointestinal tract: an update. Pharm Res 25:1663\u20131676. https:\/\/doi.org\/10.1007\/s11095-008-9569-4","journal-title":"Pharm Res"},{"key":"1642_CR44","doi-asserted-by":"publisher","DOI":"10.1016\/j.jddst.2022.103152","volume":"69","author":"Y K","year":"2022","unstructured":"K Y, Kollipara S, Ahmed T, Chachad S (2022) Applications of PBPK\/PBBM modeling in generic product development: an industry perspective. J Drug Deliv Sci Technol 69:103152. https:\/\/doi.org\/10.1016\/j.jddst.2022.103152","journal-title":"J Drug Deliv Sci Technol"},{"key":"1642_CR45","doi-asserted-by":"publisher","first-page":"1337","DOI":"10.1016\/j.ejpb.2013.09.009","volume":"85","author":"A Kambayashi","year":"2013","unstructured":"Kambayashi A, Blume H, Dressman J (2013) Understanding the in vivo performance of enteric coated tablets using an in vitro-in silico-in vivo approach: case example diclofenac. Eur J Pharm Biopharm 85:1337\u20131347. https:\/\/doi.org\/10.1016\/j.ejpb.2013.09.009","journal-title":"Eur J Pharm Biopharm"},{"key":"1642_CR46","doi-asserted-by":"publisher","first-page":"1492","DOI":"10.1208\/s12248-015-9816-7","volume":"17","author":"F Kesisoglou","year":"2015","unstructured":"Kesisoglou F, Xia B, Agrawal NG (2015) Comparison of deconvolution-based and absorption modeling IVIVC for extended release formulations of a BCS III drug development candidate. AAPS J 17:1492\u20131500. https:\/\/doi.org\/10.1208\/s12248-015-9816-7","journal-title":"AAPS J"},{"key":"1642_CR47","doi-asserted-by":"publisher","first-page":"53","DOI":"10.1021\/acs.molpharmaceut.6b00677","volume":"14","author":"TH Kim","year":"2017","unstructured":"Kim TH, Shin S, Bulitta JB, Youn YS, Yoo SD, Shin BS (2017) Development of a physiologically relevant population pharmacokinetic in vitro-in vivo correlation approach for designing extended-release oral dosage formulation. Mol Pharm 14:53\u201365. https:\/\/doi.org\/10.1021\/acs.molpharmaceut.6b00677","journal-title":"Mol Pharm"},{"key":"1642_CR48","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijpharm.2026.126631","volume":"692","author":"T Kim","year":"2026","unstructured":"Kim T, Kim TH, Shin S, Shin BS (2026) Population pharmacokinetic model-based IVIVC incorporating active metabolite kinetics: application to aceclofenac sustained-release formulations. Int J Pharm 692:126631. https:\/\/doi.org\/10.1016\/j.ijpharm.2026.126631","journal-title":"Int J Pharm"},{"key":"1642_CR49","doi-asserted-by":"publisher","first-page":"216","DOI":"10.1016\/j.jconrel.2008.06.014","volume":"130","author":"S Klein","year":"2008","unstructured":"Klein S, Rudolph MW, Skalsky B, Petereit HU, Dressman JB (2008) Use of the BioDis to generate a physiologically relevant IVIVC. J Control Release 130:216\u2013219. https:\/\/doi.org\/10.1016\/j.jconrel.2008.06.014","journal-title":"J Control Release"},{"key":"1642_CR50","doi-asserted-by":"publisher","first-page":"345","DOI":"10.1016\/j.xphs.2023.11.030","volume":"113","author":"S Kollipara","year":"2024","unstructured":"Kollipara S, Martins FS, Sanghavi M, Santos GML, Saini A, Ahmed T (2024) Role of physiologically based biopharmaceutics modeling (PBBM) in fed bioequivalence study waivers: regulatory outlook, case studies and future perspectives. J Pharm Sci 113:345\u2013358. https:\/\/doi.org\/10.1016\/j.xphs.2023.11.030","journal-title":"J Pharm Sci"},{"key":"1642_CR51","doi-asserted-by":"publisher","first-page":"300","DOI":"10.1016\/j.ejps.2013.09.008","volume":"57","author":"ES Kostewicz","year":"2014","unstructured":"Kostewicz ES, Aarons L, Bergstrand M, Bolger MB, Galetin A, Hatley O, Jamei M, Lloyd R, Pepin X, Rostami-Hodjegan A, Sjogren E, Tannergren C, Turner DB, Wagner C, Weitschies W, Dressman J (2014) PBPK models for the prediction of in vivo performance of oral dosage forms. Eur J Pharm Sci 57:300\u2013321. https:\/\/doi.org\/10.1016\/j.ejps.2013.09.008","journal-title":"Eur J Pharm Sci"},{"key":"1642_CR52","doi-asserted-by":"publisher","first-page":"21","DOI":"10.1002\/psp4.12479","volume":"9","author":"C Kuemmel","year":"2020","unstructured":"Kuemmel C, Yang Y, Zhang X, Florian J, Zhu H, Tegenge M, Huang SM, Wang Y, Morrison T, Zineh I (2020) Consideration of a credibility assessment framework in model-informed drug development: potential application to physiologically-based pharmacokinetic modeling and simulation. CPT Pharmacomet Syst Pharmacol 9:21\u201328. https:\/\/doi.org\/10.1002\/psp4.12479","journal-title":"CPT Pharmacomet Syst Pharmacol"},{"key":"1642_CR53","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejps.2019.105200","volume":"147","author":"J Kushner","year":"2020","unstructured":"Kushner J, Lamba M, Stock T, Wang R, Nemeth MA, Alvey C, Chen R, DeMatteo V, Blanchard A (2020) Development and validation of a level A in-vitro in-vivo correlation for tofacitinib modified-release tablets using extrudable core system osmotic delivery technology. Eur J Pharm Sci 147:105200. https:\/\/doi.org\/10.1016\/j.ejps.2019.105200","journal-title":"Eur J Pharm Sci"},{"key":"1642_CR54","doi-asserted-by":"publisher","first-page":"274","DOI":"10.1016\/j.xphs.2021.10.017","volume":"111","author":"M Laisney","year":"2022","unstructured":"Laisney M, Heimbach T, Mueller-Zsigmondy M, Blumenstein L, Costa R, Ji Y (2022) Physiologically based biopharmaceutics modeling to demonstrate virtual bioequivalence and bioequivalence safe-space for ribociclib which has permeation rate-controlled absorption. J Pharm Sci 111:274\u2013284. https:\/\/doi.org\/10.1016\/j.xphs.2021.10.017","journal-title":"J Pharm Sci"},{"key":"1642_CR55","doi-asserted-by":"publisher","first-page":"2769","DOI":"10.1007\/s11095-008-9641-0","volume":"25","author":"A Larsen","year":"2008","unstructured":"Larsen A, Holm R, Pedersen ML, Mullertz A (2008) Lipid-based formulations for danazol containing a digestible surfactant, Labrafil M2125CS: in vivo bioavailability and dynamic in vitro lipolysis. Pharm Res 25:2769\u20132777. https:\/\/doi.org\/10.1007\/s11095-008-9641-0","journal-title":"Pharm Res"},{"key":"1642_CR56","doi-asserted-by":"publisher","first-page":"1226","DOI":"10.3390\/pharmaceutics14061226","volume":"14","author":"DY Lee","year":"2022","unstructured":"Lee DY, Shin S, Kim TH, Shin BS (2022) Establishment of level A In Vitro-In Vivo correlation (IVIVC) via extended DoE-IVIVC model: a donepezil case study. Pharmaceutics 14:1226. https:\/\/doi.org\/10.3390\/pharmaceutics14061226","journal-title":"Pharmaceutics"},{"key":"1642_CR57","doi-asserted-by":"publisher","first-page":"82","DOI":"10.1002\/psp4.12260","volume":"7","author":"M Li","year":"2018","unstructured":"Li M, Zhao P, Pan Y, Wagner C (2018) Predictive performance of physiologically based pharmacokinetic models for the effect of food on oral drug absorption: current status. CPT Pharmacometrics Syst Pharmacol 7:82\u201389. https:\/\/doi.org\/10.1002\/psp4.12260","journal-title":"CPT Pharmacometrics Syst Pharmacol"},{"key":"1642_CR58","doi-asserted-by":"publisher","first-page":"443","DOI":"10.1016\/j.jconrel.2022.01.048","volume":"343","author":"JY Lim","year":"2022","unstructured":"Lim JY, Kim TH, Song CH, Kim DH, Shin BS, Shin S (2022) Novel extended IVIVC combined with DoE to predict pharmacokinetics from formulation compositions. J Control Release 343:443\u2013456. https:\/\/doi.org\/10.1016\/j.jconrel.2022.01.048","journal-title":"J Control Release"},{"key":"1642_CR59","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejps.2020.105297","volume":"149","author":"C Litou","year":"2020","unstructured":"Litou C, Turner DB, Holmstock N, Ceulemans J, Box KJ, Kostewicz E, Kuentz M, Holm R, Dressman J (2020) Combining biorelevant in vitro and in silico tools to investigate the in vivo performance of the amorphous solid dispersion formulation of etravirine in the fed state. Eur J Pharm Sci 149:105297. https:\/\/doi.org\/10.1016\/j.ejps.2020.105297","journal-title":"Eur J Pharm Sci"},{"key":"1642_CR60","doi-asserted-by":"publisher","first-page":"918","DOI":"10.1002\/jps.2600570602","volume":"57","author":"JC Loo","year":"1968","unstructured":"Loo JC, Riegelman S (1968) New method for calculating the intrinsic absorption rate of drugs. J Pharm Sci 57:918\u2013928. https:\/\/doi.org\/10.1002\/jps.2600570602","journal-title":"J Pharm Sci"},{"key":"1642_CR61","doi-asserted-by":"publisher","DOI":"10.1016\/j.addr.2026.115856","volume":"233","author":"H Lou","year":"2026","unstructured":"Lou H, Zhang Y (2026) Emerging techniques for modeling and simulating subcutaneous injection and fate of drugs after injection. Adv Drug Deliv Rev 233:115856. https:\/\/doi.org\/10.1016\/j.addr.2026.115856","journal-title":"Adv Drug Deliv Rev"},{"key":"1642_CR62","doi-asserted-by":"publisher","first-page":"142","DOI":"10.1016\/j.ijpharm.2011.01.010","volume":"418","author":"Y Lu","year":"2011","unstructured":"Lu Y, Kim S, Park K (2011) In vitro-in vivo correlation: perspectives on model development. Int J Pharm 418:142\u2013148. https:\/\/doi.org\/10.1016\/j.ijpharm.2011.01.010","journal-title":"Int J Pharm"},{"key":"1642_CR63","doi-asserted-by":"publisher","first-page":"2065","DOI":"10.1021\/acs.molpharmaceut.4c00202","volume":"21","author":"C Mackie","year":"2024","unstructured":"Mackie C, Arora S, Seo P, Moody R, Rege B, Pepin X, Heimbach T, Tannergren C, Mitra A, Suarez-Sharp S, Borges LN, Kijima S, Kotzagiorgis E, Malamatari M, Veerasingham S, Polli JE, Rullo G (2024) Physiologically based biopharmaceutics modeling (PBBM): best practices for drug product quality, regulatory and industry perspectives: 2023 workshop summary report. Mol Pharm 21:2065\u20132080. https:\/\/doi.org\/10.1021\/acs.molpharmaceut.4c00202","journal-title":"Mol Pharm"},{"key":"1642_CR64","doi-asserted-by":"publisher","DOI":"10.3390\/ph18121894","volume":"18","author":"FS Martins","year":"2025","unstructured":"Martins FS, Borges LL, Kollipara S, Sivadasu P, Couto ROD (2025) DoE- and PBBM-driven formulation development of an extended-release donepezil tablet. Pharmaceuticals (Basel) 18:1894. https:\/\/doi.org\/10.3390\/ph18121894","journal-title":"Pharmaceuticals (Basel)"},{"key":"1642_CR65","doi-asserted-by":"publisher","DOI":"10.3390\/pharmaceutics14051010","volume":"14","author":"M McAllister","year":"2022","unstructured":"McAllister M, Flanagan T, Cole S, Abend A, Kotzagiorgis E, Limberg J, Mead H, Mangas-Sanjuan V, Dickinson PA, Moir A, Pepin X, Zhou D, Tistaert C, Dokoumetzidis A, Anand O, Le Merdy M, Turner DB, Griffin BT, Darwich A, Dressman J, Mackie C (2022) Developing clinically relevant dissolution specifications (CRDSs) for oral drug products: virtual webinar series. Pharmaceutics 14:1010. https:\/\/doi.org\/10.3390\/pharmaceutics14051010","journal-title":"Pharmaceutics"},{"key":"1642_CR66","doi-asserted-by":"publisher","unstructured":"McAllister M, Mistry N, Pepin X, Cole S, Tannergren C, Stamatopoulos K, Engman H, Moir A, Litou C, Gavins F, Arora S, Malamatari M, Guimaraes M, Ravi A, Fotaki N, Dodd L, Holte O, Butler J, Dickinson PA, Popkin M, Butler A, NiOgain O, Holmstock N, Mackie C (2026) Physiologically based biopharmaceutics modelling-best scientific practices to define drug product performance, latest regulatory and industry perspectives: workshop summary report. Pharmaceutics 18:566 https:\/\/doi.org\/10.3390\/pharmaceutics18050566","DOI":"10.3390\/pharmaceutics18050566"},{"key":"1642_CR67","doi-asserted-by":"publisher","first-page":"524","DOI":"10.1002\/psp4.13110","volume":"13","author":"N Milani","year":"2024","unstructured":"Milani N, Parrott N, Galetin A, Fowler S, Gertz M (2024) In silico modeling and simulation of organ-on-a-chip systems to support data analysis and a priori experimental design. CPT Pharmacomet Syst Pharmacol 13:524\u2013543. https:\/\/doi.org\/10.1002\/psp4.13110","journal-title":"CPT Pharmacomet Syst Pharmacol"},{"key":"1642_CR68","doi-asserted-by":"publisher","first-page":"179","DOI":"10.1007\/s11095-012-0861-y","volume":"30","author":"T Mirza","year":"2013","unstructured":"Mirza T, Bykadi SA, Ellison CD, Yang Y, Davit BM, Khan MA (2013) Use of in vitro-in vivo correlation to predict the pharmacokinetics of several products containing a BCS class 1 drug in extended release matrices. Pharm Res 30:179\u2013190. https:\/\/doi.org\/10.1007\/s11095-012-0861-y","journal-title":"Pharm Res"},{"key":"1642_CR69","doi-asserted-by":"publisher","first-page":"594","DOI":"10.1016\/j.xphs.2020.10.059","volume":"110","author":"A Mitra","year":"2021","unstructured":"Mitra A, Suarez-Sharp S, Pepin XJH, Flanagan T, Zhao Y, Kotzagiorgis E, Parrott N, Sharan S, Tistaert C, Heimbach T, Zolnik B, Sjogren E, Wu F, Anand O, Kakar S, Li M, Veerasingham S, Kijima S, Lima Santos GM, Ning B, Raines K, Rullo G, Mandula H, Delvadia P, Dressman J, Dickinson PA, Babiskin A (2021) Applications of physiologically based biopharmaceutics modeling (PBBM) to support drug product quality: a workshop summary report. J Pharm Sci 110:594\u2013609. https:\/\/doi.org\/10.1016\/j.xphs.2020.10.059","journal-title":"J Pharm Sci"},{"key":"1642_CR70","doi-asserted-by":"publisher","first-page":"1187","DOI":"10.1007\/s11095-017-2133-3","volume":"34","author":"RK Mittapalli","year":"2017","unstructured":"Mittapalli RK, Nuthalapati S, Delke DeBord AE, Xiong H (2017) Development of a level A in vitro-in vivo correlation for veliparib (ABT-888) extended release tablet formulation. Pharm Res 34:1187\u20131192. https:\/\/doi.org\/10.1007\/s11095-017-2133-3","journal-title":"Pharm Res"},{"key":"1642_CR71","doi-asserted-by":"publisher","first-page":"108","DOI":"10.1208\/s12248-019-0378-y","volume":"21","author":"MF Mohamed","year":"2019","unstructured":"Mohamed MF, Trueman S, Othman AA, Han JH, Ju TR, Marroum P (2019) Development of in vitro-in vivo correlation for upadacitinib extended-release tablet formulation. AAPS J 21:108. https:\/\/doi.org\/10.1208\/s12248-019-0378-y","journal-title":"AAPS J"},{"key":"1642_CR72","doi-asserted-by":"publisher","first-page":"981","DOI":"10.1208\/s12248-016-9918-x","volume":"18","author":"AM Nader","year":"2016","unstructured":"Nader AM, Quinney SK, Fadda HM, Foster DR (2016) Effect of gastric fluid volume on the in vitro dissolution and in vivo absorption of BCS class II drugs: a case study with nifedipine. AAPS J 18:981\u2013988. https:\/\/doi.org\/10.1208\/s12248-016-9918-x","journal-title":"AAPS J"},{"key":"1642_CR73","doi-asserted-by":"publisher","first-page":"333","DOI":"10.1016\/j.ejpb.2017.04.026","volume":"117","author":"AS Narang","year":"2017","unstructured":"Narang AS, Balakrishnan A, Morrison J, Li J, Wang J, Gu H, Taylor K, Santone K, Ehrmann J, Beyer S, Lu X, Ketner R, Pizzano J, Orcutt T, Shields E, Dulac H, Aborn S, Batchelder M, Lentz K (2017) Role of regional absorption and gastrointestinal motility on variability in oral absorption of a model drug. Eur J Pharm Biopharm 117:333\u2013345. https:\/\/doi.org\/10.1016\/j.ejpb.2017.04.026","journal-title":"Eur J Pharm Biopharm"},{"key":"1642_CR74","doi-asserted-by":"publisher","first-page":"1355","DOI":"10.1002\/jps.23031","volume":"101","author":"A Newman","year":"2012","unstructured":"Newman A, Knipp G, Zografi G (2012) Assessing the performance of amorphous solid dispersions. J Pharm Sci 101:1355\u20131377. https:\/\/doi.org\/10.1002\/jps.23031","journal-title":"J Pharm Sci"},{"key":"1642_CR75","doi-asserted-by":"publisher","first-page":"277","DOI":"10.1023\/a:1011531226478","volume":"28","author":"T O\u2019Hara","year":"2001","unstructured":"O\u2019Hara T, Hayes S, Davis J, Devane J, Smart T, Dunne A (2001) In vivo-in vitro correlation (IVIVC) modeling incorporating a convolution step. J Pharmacokinet Pharmacodyn 28:277\u2013298. https:\/\/doi.org\/10.1023\/a:1011531226478","journal-title":"J Pharmacokinet Pharmacodyn"},{"key":"1642_CR76","doi-asserted-by":"publisher","DOI":"10.1016\/j.addr.2023.114906","volume":"199","author":"G Pastorin","year":"2023","unstructured":"Pastorin G, Benetti C, Wacker MG (2023) From in vitro to in vivo: a comprehensive guide to IVIVC development for long-acting therapeutics. Adv Drug Deliv Rev 199:114906. https:\/\/doi.org\/10.1016\/j.addr.2023.114906","journal-title":"Adv Drug Deliv Rev"},{"key":"1642_CR77","doi-asserted-by":"publisher","first-page":"435","DOI":"10.1016\/j.ejpb.2019.07.011","volume":"142","author":"XJH Pepin","year":"2019","unstructured":"Pepin XJH, Moir AJ, Mann JC, Sanderson NJ, Barker R, Meehan E, Plumb AP, Bailey GR, Murphy DS, Krejsa CM, Andrew MA, Ingallinera TG, Slatter JG (2019) Bridging in vitro dissolution and in vivo exposure for acalabrutinib. Part II. A mechanistic PBPK model for IR formulation comparison, proton pump inhibitor drug interactions, and administration with acidic juices. Eur J Pharm Biopharm 142:435\u2013448. https:\/\/doi.org\/10.1016\/j.ejpb.2019.07.011","journal-title":"Eur J Pharm Biopharm"},{"key":"1642_CR78","doi-asserted-by":"publisher","first-page":"3697","DOI":"10.1021\/acs.molpharmaceut.4c00526","volume":"21","author":"X Pepin","year":"2024","unstructured":"Pepin X, Arora S, Borges L, Cano-Vega M, Carducci T, Chatterjee P, Chen G, Cristofoletti R, Dallmann A, Delvadia P, Dressman J, Fotaki N, Gray E, Heimbach T, Holte O, Kijima S, Kotzagiorgis K, Lennernas H, Lindahl A, Loebenberg R, Mackie C, Malamatari M, McAllister M, Mitra A, Moody R, Mudie D, Musuamba Tshinanu F, Polli JE, Rege B, Ren X, Rullo G, Scherholz M, Song I, Stillhart C, Suarez-Sharp S, Tannergren C, Tsakalozou E, Veerasingham S, Wagner C, Seo P (2024) Parameterization of physiologically based biopharmaceutics models: workshop summary report. Mol Pharm 21:3697\u20133731. https:\/\/doi.org\/10.1021\/acs.molpharmaceut.4c00526","journal-title":"Mol Pharm"},{"key":"1642_CR79","doi-asserted-by":"publisher","first-page":"742","DOI":"10.1002\/cpt.1778","volume":"107","author":"TM Polasek","year":"2020","unstructured":"Polasek TM, Rostami-Hodjegan A (2020) Virtual twins: understanding the data required for model-informed precision dosing. Clin Pharmacol Ther 107:742\u2013745. https:\/\/doi.org\/10.1002\/cpt.1778","journal-title":"Clin Pharmacol Ther"},{"key":"1642_CR80","doi-asserted-by":"publisher","first-page":"627","DOI":"10.1208\/s12248-012-9376-z","volume":"14","author":"JE Polli","year":"2012","unstructured":"Polli JE, Cook JA, Davit BM, Dickinson PA, Argenti D, Barbour N, Garcia-Arieta A, Geoffroy JM, Hartauer K, Li S, Mitra A, Muller FX, Purohit V, Sanchez-Felix M, Skoug JW, Tang K (2012) Summary workshop report: facilitating oral product development and reducing regulatory burden through novel approaches to assess bioavailability\/bioequivalence. AAPS J 14:627\u2013638. https:\/\/doi.org\/10.1208\/s12248-012-9376-z","journal-title":"AAPS J"},{"key":"1642_CR81","doi-asserted-by":"publisher","first-page":"2765","DOI":"10.1007\/s11095-012-0695-7","volume":"29","author":"F Qian","year":"2012","unstructured":"Qian F, Wang J, Hartley R, Tao J, Haddadin R, Mathias N, Hussain M (2012) Solution behavior of PVP-VA and HPMC-AS-based amorphous solid dispersions and their bioavailability implications. Pharm Res 29:2765\u20132776. https:\/\/doi.org\/10.1007\/s11095-012-0695-7","journal-title":"Pharm Res"},{"key":"1642_CR82","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejps.2025.107047","volume":"209","author":"N Rudolph","year":"2025","unstructured":"Rudolph N, Charbe N, Plano D, Shoyaib AA, Pal A, Boyce H, Zhao L, Wu F, Polli J, Dressman J, Cristofoletti R (2025) A physiologically based biopharmaceutics modeling (PBBM) framework for characterizing formulation-dependent food effects: paving the road towards fed state virtual BE studies for itraconazole amorphous solid dispersions. Eur J Pharm Sci 209:107047. https:\/\/doi.org\/10.1016\/j.ejps.2025.107047","journal-title":"Eur J Pharm Sci"},{"key":"1642_CR83","doi-asserted-by":"publisher","DOI":"10.3390\/pharmaceutics11120663","volume":"11","author":"A Ruiz-Picazo","year":"2019","unstructured":"Ruiz-Picazo A, Colon-Useche S, Perez-Amoros B, Gonzalez-Alvarez M, Molina-Martinez I, Gonzalez-Alvarez I, Garcia-Arieta A, Bermejo M (2019) Investigation to explain bioequivalence failure in pravastatin immediate-release products. Pharmaceutics 11:663. https:\/\/doi.org\/10.3390\/pharmaceutics11120663","journal-title":"Pharmaceutics"},{"key":"1642_CR84","doi-asserted-by":"publisher","first-page":"971","DOI":"10.1111\/j.1365-2036.2005.02683.x","volume":"22","author":"C Schiller","year":"2005","unstructured":"Schiller C, Frohlich CP, Giessmann T, Siegmund W, Monnikes H, Hosten N, Weitschies W (2005) Intestinal fluid volumes and transit of dosage forms as assessed by magnetic resonance imaging. Aliment Pharmacol Ther 22:971\u2013979. https:\/\/doi.org\/10.1111\/j.1365-2036.2005.02683.x","journal-title":"Aliment Pharmacol Ther"},{"key":"1642_CR85","doi-asserted-by":"publisher","first-page":"445","DOI":"10.1007\/BF01061728","volume":"5","author":"LB Sheiner","year":"1977","unstructured":"Sheiner LB, Rosenberg B, Marathe VV (1977) Estimation of population characteristics of pharmacokinetic parameters from routine clinical data. J Pharmacokinet Biopharm 5:445\u2013479. https:\/\/doi.org\/10.1007\/BF01061728","journal-title":"J Pharmacokinet Biopharm"},{"key":"1642_CR86","doi-asserted-by":"publisher","first-page":"2","DOI":"10.1016\/j.jconrel.2015.09.051","volume":"218","author":"J Shen","year":"2015","unstructured":"Shen J, Choi S, Qu W, Wang Y, Burgess DJ (2015) In vitro-in vivo correlation of parenteral risperidone polymeric microspheres. J Control Release 218:2\u201312. https:\/\/doi.org\/10.1016\/j.jconrel.2015.09.051","journal-title":"J Control Release"},{"key":"1642_CR87","doi-asserted-by":"publisher","first-page":"27","DOI":"10.1208\/s12248-019-0382-2","volume":"22","author":"S Shin","year":"2020","unstructured":"Shin S, Kim TH, Lee DY, Chung SE, Lee JB, Kim DH, Shin BS (2020) Development of a population pharmacokinetics-based in vitro-in vivo correlation model for drugs with site-dependent absorption: the acyclovir case study. AAPS J 22:27. https:\/\/doi.org\/10.1208\/s12248-019-0382-2","journal-title":"AAPS J"},{"key":"1642_CR88","doi-asserted-by":"publisher","first-page":"95","DOI":"10.1016\/j.ejpb.2010.05.009","volume":"76","author":"Y Shono","year":"2010","unstructured":"Shono Y, Jantratid E, Kesisoglou F, Reppas C, Dressman JB (2010) Forecasting in vivo oral absorption and food effect of micronized and nanosized aprepitant formulations in humans. Eur J Pharm Biopharm 76:95\u2013104. https:\/\/doi.org\/10.1016\/j.ejpb.2010.05.009","journal-title":"Eur J Pharm Biopharm"},{"key":"1642_CR89","doi-asserted-by":"publisher","first-page":"91","DOI":"10.1016\/j.ejpb.2022.06.009","volume":"177","author":"M Singhal","year":"2022","unstructured":"Singhal M, Turunen E, Ahtola-Satila T, Aspegren J, Bratty JR, Fuhr R, Ojala K, van Veen B, Peltonen L (2022) Nanoparticle-based oral formulation can surprise you with inferior in vivo absorption in humans. Eur J Pharm Biopharm 177:91\u201399. https:\/\/doi.org\/10.1016\/j.ejpb.2022.06.009","journal-title":"Eur J Pharm Biopharm"},{"key":"1642_CR90","doi-asserted-by":"publisher","first-page":"587","DOI":"10.1208\/s12248-016-0038-4","volume":"19","author":"SD Siqueira","year":"2017","unstructured":"Siqueira SD, Mullertz A, Graeser K, Kasten G, Mu H, Rades T (2017) Influence of drug load and physical form of cinnarizine in new SNEDDS dosing regimens: in vivo and in vitro evaluations. AAPS J 19:587\u2013594. https:\/\/doi.org\/10.1208\/s12248-016-0038-4","journal-title":"AAPS J"},{"key":"1642_CR91","doi-asserted-by":"publisher","first-page":"301","DOI":"10.1016\/s0939-6411(01)00248-x","volume":"53","author":"N Sirisuth","year":"2002","unstructured":"Sirisuth N, Eddington ND (2002) The influence of first pass metabolism on the development and validation of an IVIVC for metoprolol extended release tablets. Eur J Pharm Biopharm 53:301\u2013309. https:\/\/doi.org\/10.1016\/s0939-6411(01)00248-x","journal-title":"Eur J Pharm Biopharm"},{"key":"1642_CR92","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1002\/bdd.270","volume":"23","author":"N Sirisuth","year":"2002","unstructured":"Sirisuth N, Augsburger LL, Eddington ND (2002) Development and validation of a non-linear IVIVC model for a diltiazem extended release formulation. Biopharm Drug Dispos 23:1\u20138. https:\/\/doi.org\/10.1002\/bdd.270","journal-title":"Biopharm Drug Dispos"},{"key":"1642_CR93","doi-asserted-by":"publisher","first-page":"376","DOI":"10.1016\/j.ejpb.2012.07.011","volume":"82","author":"M \u0160tefani\u010d","year":"2012","unstructured":"\u0160tefani\u010d M, Locatelli I, Vre\u010der F, Sever T, Mrhar A, Bogataj M (2012) The influence of gastric emptying kinetics on the drug release from enteric coated pellets in fasted state: an in vitro\/in vivo correlation. Eur J Pharm Biopharm 82:376\u2013382. https:\/\/doi.org\/10.1016\/j.ejpb.2012.07.011","journal-title":"Eur J Pharm Biopharm"},{"key":"1642_CR94","doi-asserted-by":"publisher","DOI":"10.1208\/s12248-019-0292-3","volume":"21","author":"C Stillhart","year":"2019","unstructured":"Stillhart C, Pepin X, Tistaert C, Good D, Van Den Bergh A, Parrott N, Kesisoglou F (2019) PBPK absorption modeling: establishing the in vitro-in vivo link-industry perspective. AAPS J 21:19. https:\/\/doi.org\/10.1208\/s12248-019-0292-3","journal-title":"AAPS J"},{"key":"1642_CR95","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejps.2020.105280","volume":"147","author":"C Stillhart","year":"2020","unstructured":"Stillhart C, Vucicevic K, Augustijns P, Basit AW, Batchelor H, Flanagan TR, Gesquiere I, Greupink R, Keszthelyi D, Koskinen M, Madla CM, Matthys C, Miljus G, Mooij MG, Parrott N, Ungell AL, de Wildt SN, Orlu M, Klein S, Mullertz A (2020) Impact of gastrointestinal physiology on drug absorption in special populations\u2013An UNGAP review. Eur J Pharm Sci 147:105280. https:\/\/doi.org\/10.1016\/j.ejps.2020.105280","journal-title":"Eur J Pharm Sci"},{"key":"1642_CR96","doi-asserted-by":"publisher","first-page":"1379","DOI":"10.1208\/s12248-016-9966-2","volume":"18","author":"S Suarez-Sharp","year":"2016","unstructured":"Suarez-Sharp S, Li M, Duan J, Shah H, Seo P (2016) Regulatory experience with in vivo in vitro correlations (IVIVC) in new drug applications. AAPS J 18:1379\u20131390. https:\/\/doi.org\/10.1208\/s12248-016-9966-2","journal-title":"AAPS J"},{"key":"1642_CR97","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejpb.2024.114479","volume":"204","author":"Y Takahashi","year":"2024","unstructured":"Takahashi Y, Kambayashi A (2024) Physiologically based in vitro - in vivo correlation of modified release oral formulations with non-linear intestinal absorption: a case study using mirabegron. Eur J Pharm Biopharm 204:114479. https:\/\/doi.org\/10.1016\/j.ejpb.2024.114479","journal-title":"Eur J Pharm Biopharm"},{"key":"1642_CR98","doi-asserted-by":"publisher","first-page":"5","DOI":"10.1021\/acs.molpharmaceut.4c01148","volume":"22","author":"C Tannergren","year":"2025","unstructured":"Tannergren C, Arora S, Babiskin A, Borges L, Chatterjee P, Cheng YH, Dallmann A, Govada A, Heimbach T, Hingle M, Kollipara S, Kotzagiorgis E, Lindahl A, Mackie C, Malamatari M, Mitra A, Moody R, Pepin X, Polli J, Raines K, Rullo G, Sanghavi M, Savkur R, Singh R, Sjogren E, Suarez-Sharp S, Thomas S, Veerasingham S, Wei K, Wu F, Xu Y, Yoon M, Rege B (2025) Current state and new horizons in applications of physiologically based biopharmaceutics modeling (PBBM): a workshop report. Mol Pharm 22:5\u201327. https:\/\/doi.org\/10.1021\/acs.molpharmaceut.4c01148","journal-title":"Mol Pharm"},{"key":"1642_CR99","doi-asserted-by":"publisher","first-page":"127","DOI":"10.1016\/S0168-3659(01)00268-1","volume":"72","author":"VRS Uppoor","year":"2001","unstructured":"Uppoor VRS (2001) Regulatory perspectives on in vitro (dissolution)\/in vivo (bioavailability) correlations. J Control Release 72:127\u2013132. https:\/\/doi.org\/10.1016\/S0168-3659(01)00268-1","journal-title":"J Control Release"},{"key":"1642_CR100","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejps.2021.105812","volume":"162","author":"Z Vinarov","year":"2021","unstructured":"Vinarov Z, Abdallah M, Agundez JAG, Allegaert K, Basit AW, Braeckmans M, Ceulemans J, Corsetti M, Griffin BT, Grimm M, Keszthelyi D, Koziolek M, Madla CM, Matthys C, McCoubrey LE, Mitra A, Reppas C, Stappaerts J, Steenackers N, Trevaskis NL, Vanuytsel T, Vertzoni M, Weitschies W, Wilson C, Augustijns P (2021) Impact of gastrointestinal tract variability on oral drug absorption and pharmacokinetics: an UNGAP review. Eur J Pharm Sci 162:105812. https:\/\/doi.org\/10.1016\/j.ejps.2021.105812","journal-title":"Eur J Pharm Sci"},{"key":"1642_CR101","doi-asserted-by":"publisher","first-page":"610","DOI":"10.1002\/jps.2600520629","volume":"52","author":"JG Wagner","year":"1963","unstructured":"Wagner JG, Nelson E (1963) Per cent absorbed time plots derived from blood level and\/or urinary excretion data. J Pharm Sci 52:610\u2013611. https:\/\/doi.org\/10.1002\/jps.2600520629","journal-title":"J Pharm Sci"},{"key":"1642_CR102","doi-asserted-by":"publisher","first-page":"347","DOI":"10.1016\/j.jconrel.2022.05.014","volume":"347","author":"B Wan","year":"2022","unstructured":"Wan B, Bao Q, Burgess DJ (2022) In vitro-in vivo correlation of PLGA microspheres: effect of polymer source variation and temperature. J Control Release 347:347\u2013355. https:\/\/doi.org\/10.1016\/j.jconrel.2022.05.014","journal-title":"J Control Release"},{"key":"1642_CR103","doi-asserted-by":"publisher","DOI":"10.1016\/j.xphs.2026.104277","volume":"115","author":"B Wan","year":"2026","unstructured":"Wan B, Veettil SRU, Li Y, Ho T, Foti C, Meena Harish Jain K (2026) Development of in vitro\/in vivo correlation for long-acting injectable suspensions via bootstrapping. J Pharm Sci 115:104277. https:\/\/doi.org\/10.1016\/j.xphs.2026.104277","journal-title":"J Pharm Sci"},{"key":"1642_CR104","doi-asserted-by":"publisher","first-page":"186","DOI":"10.1016\/j.jconrel.2024.11.021","volume":"377","author":"Y Wang","year":"2025","unstructured":"Wang Y, Otte A, Park H, Park K (2025) In vitro-in vivo correlation (IVIVC) development for long-acting injectable drug products based on poly(lactide-co-glycolide). J Control Release 377:186\u2013196. https:\/\/doi.org\/10.1016\/j.jconrel.2024.11.021","journal-title":"J Control Release"},{"key":"1642_CR105","doi-asserted-by":"publisher","first-page":"4022","DOI":"10.1021\/jm030999b","volume":"47","author":"S Willmann","year":"2004","unstructured":"Willmann S, Schmitt W, Keldenich J, Lippert J, Dressman JB (2004) A physiological model for the estimation of the fraction dose absorbed in humans. J Med Chem 47:4022\u20134031. https:\/\/doi.org\/10.1021\/jm030999b","journal-title":"J Med Chem"},{"key":"1642_CR106","doi-asserted-by":"publisher","first-page":"337","DOI":"10.1007\/s11095-022-03319-6","volume":"40","author":"D Wu","year":"2023","unstructured":"Wu D, Sanghavi M, Kollipara S, Ahmed T, Saini AK, Heimbach T (2023) Physiologically based pharmacokinetics modeling in biopharmaceutics: case studies for establishing the bioequivalence safe space for innovator and generic drugs. Pharm Res 40:337\u2013357. https:\/\/doi.org\/10.1007\/s11095-022-03319-6","journal-title":"Pharm Res"},{"key":"1642_CR107","doi-asserted-by":"publisher","first-page":"476","DOI":"10.1016\/j.xphs.2017.06.018","volume":"107","author":"H Xu","year":"2018","unstructured":"Xu H, Shi Y, Vela S, Marroum P, Gao P (2018) Developing quantitative in vitro-in vivo correlation for fenofibrate immediate-release formulations with the biphasic dissolution-partition test method. J Pharm Sci 107:476\u2013487. https:\/\/doi.org\/10.1016\/j.xphs.2017.06.018","journal-title":"J Pharm Sci"},{"key":"1642_CR108","doi-asserted-by":"publisher","first-page":"119","DOI":"10.1016\/s0378-5173(99)00147-7","volume":"186","author":"LX Yu","year":"1999","unstructured":"Yu LX, Amidon GL (1999) A compartmental absorption and transit model for estimating oral drug absorption. Int J Pharm 186:119\u2013125. https:\/\/doi.org\/10.1016\/s0378-5173(99)00147-7","journal-title":"Int J Pharm"},{"key":"1642_CR109","doi-asserted-by":"publisher","first-page":"275","DOI":"10.1016\/j.jconrel.2022.04.024","volume":"346","author":"Y Zhang","year":"2022","unstructured":"Zhang Y, Wo SK, Leng W, Gao F, Yan X, Zuo Z (2022) Population pharmacokinetics and IVIVC for mesalazine enteric-coated tablets. J Control Release 346:275\u2013288. https:\/\/doi.org\/10.1016\/j.jconrel.2022.04.024","journal-title":"J Control Release"},{"key":"1642_CR110","doi-asserted-by":"publisher","DOI":"10.3390\/pharmaceutics17101352","volume":"17","author":"C Zhao","year":"2025","unstructured":"Zhao C, Shen C, Xiao Y, Wang L (2025) Virtual bioequivalence assessment and dissolution safe space exploration for fixed-dose metformin-glyburide tablet using physiologically based biopharmaceutics modeling. Pharmaceutics 17:1352. https:\/\/doi.org\/10.3390\/pharmaceutics17101352","journal-title":"Pharmaceutics"},{"key":"1642_CR111","unstructured":"FDA (1997) Guidance for industry: extended release oral dosage forms: development, evaluation, and application of In Vitro\/In Vivo correlations. U.S. Food and Drug Administration, Silver Spring, MD"},{"key":"1642_CR112","unstructured":"FDA (2020) The use of physiologically based pharmacokinetic analyses \u2014 biopharmaceutics applications for oral drug product development, manufacturing changes, and controls. Guidance for Industry (Draft Guidance). U.S. Food and Drug Administration, Silver Spring, MD"},{"key":"1642_CR113","unstructured":"ICH (2019) Biopharmaceutics classification system-based biowaivers M9. International Council for Harmonisation, Geneva, Switzerland"}],"container-title":["Archives of Pharmacal Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s12272-026-01642-9.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s12272-026-01642-9","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s12272-026-01642-9.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T16:03:57Z","timestamp":1791907437000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s12272-026-01642-9"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,10,13]]},"references-count":113,"alternative-id":["1642"],"URL":"https:\/\/doi.org\/10.1007\/s12272-026-01642-9","relation":{},"ISSN":["0253-6269","1976-3786"],"issn-type":[{"value":"0253-6269","type":"print"},{"value":"1976-3786","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,10,13]]},"assertion":[{"value":"9 June 2026","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"29 September 2026","order":2,"name":"revised","label":"Revised","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"29 September 2026","order":3,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"13 October 2026","order":4,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"Shin S is an Associate Editor of this journal, Archives of Pharmacal Research. However, this position did not influence the editorial handling or peer review process of this manuscript. The other author declares no conflict of interest.","order":1,"name":"Ethics","label":"Conflict of interest","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":2,"name":"Ethics","label":"Ethical approval","group":{"name":"EthicsHeading","label":"Declarations"}}]}}