{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,20]],"date-time":"2026-03-20T10:48:05Z","timestamp":1774003685845,"version":"3.50.1"},"reference-count":24,"publisher":"Elsevier BV","issue":"9","license":[{"start":{"date-parts":[[2024,9,1]],"date-time":"2024-09-01T00:00:00Z","timestamp":1725148800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2024,9,1]],"date-time":"2024-09-01T00:00:00Z","timestamp":1725148800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"}],"funder":[{"DOI":"10.13039\/100004328","name":"Genentech Inc","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004328","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["jpharmsci.org","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Journal of Pharmaceutical Sciences"],"published-print":{"date-parts":[[2024,9]]},"DOI":"10.1016\/j.xphs.2024.07.006","type":"journal-article","created":{"date-parts":[[2024,7,14]],"date-time":"2024-07-14T05:04:40Z","timestamp":1720933480000},"page":"2952-2956","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":1,"title":["Integrating Dynamic in vitro Systems and Mechanistic Absorption Modeling: Case Study of Pralsetinib"],"prefix":"10.1016","volume":"113","author":[{"given":"Michael J.","family":"Dolton","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5666-6675","authenticated-orcid":false,"given":"Christine","family":"Bowman","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fang","family":"Ma","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2933-6328","authenticated-orcid":false,"given":"Sravanthi","family":"Cheeti","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4547-9572","authenticated-orcid":false,"given":"Denison","family":"Kuruvilla","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6193-2993","authenticated-orcid":false,"given":"Nastya","family":"Kassir","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuan","family":"Chen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jia","family":"Liu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Po-Chang","family":"Chiang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"78","reference":[{"key":"10.1016\/j.xphs.2024.07.006_bib0001","doi-asserted-by":"crossref","first-page":"342","DOI":"10.1016\/j.jddst.2015.05.009","article-title":"Strategies for formulating and delivering poorly water-soluble drugs","volume":"30","author":"Rodriguez-Aller","year":"2015","journal-title":"J Drug Deliv Sci Tech"},{"issue":"1","key":"10.1016\/j.xphs.2024.07.006_bib0002","doi-asserted-by":"crossref","first-page":"43","DOI":"10.1211\/0022357022511","article-title":"Predicting the precipitation of poorly soluble weak bases upon entry in the small intestine","volume":"56","author":"Kostewicz","year":"2004","journal-title":"J Pharm Pharmacol"},{"key":"10.1016\/j.xphs.2024.07.006_bib0003","doi-asserted-by":"crossref","DOI":"10.1016\/j.ijpharm.2021.120505","article-title":"Prediction of in vivo supersaturation and precipitation of poorly water-soluble drugs: achievements and aspirations","volume":"600","author":"Thakral","year":"2021","journal-title":"Int J Pharm"},{"issue":"1","key":"10.1016\/j.xphs.2024.07.006_bib0004","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1080\/03639045.2021.1879843","article-title":"A mechanistic review on the dissolution phase behavior and supersaturation stabilization of amorphous solid dispersions","volume":"47","author":"Ashwathy","year":"2021","journal-title":"Drug Dev Ind Pharm"},{"issue":"1","key":"10.1016\/j.xphs.2024.07.006_bib0005","doi-asserted-by":"crossref","first-page":"25","DOI":"10.1016\/j.ijpharm.2012.11.026","article-title":"Evaluation of gastrointestinal drug supersaturation and precipitation: strategies and issues","volume":"453","author":"Bevernage","year":"2013","journal-title":"Int J Pharm"},{"issue":"8","key":"10.1016\/j.xphs.2024.07.006_bib0006","doi-asserted-by":"crossref","first-page":"3020","DOI":"10.1016\/j.xphs.2021.04.017","article-title":"Utilizing tiny-TIM to assess the effect of acid-reducing agents on the absorption of orally administered drugs","volume":"110","author":"Liu","year":"2021","journal-title":"J Pharm Sci"},{"issue":"7","key":"10.1016\/j.xphs.2024.07.006_bib0007","doi-asserted-by":"crossref","first-page":"2018","DOI":"10.1016\/j.xphs.2022.01.024","article-title":"Evaluating the IVIVC by combining tiny-tim outputs and compartmental PK model to predict oral exposure for different formulations of ibuprofen","volume":"111","author":"Chiang","year":"2022","journal-title":"J Pharm Sci"},{"issue":"1","key":"10.1016\/j.xphs.2024.07.006_bib0008","doi-asserted-by":"crossref","first-page":"178","DOI":"10.1016\/j.ijpharm.2015.11.048","article-title":"Evaluation of two dynamic in vitro models simulating fasted and fed state conditions in the upper gastrointestinal tract (TIM-1 and tiny-TIM) for investigating the bioaccessibility of pharmaceutical compounds from oral dosage forms","volume":"498","author":"Verwei","year":"2016","journal-title":"Int J Pharm"},{"issue":"9","key":"10.1016\/j.xphs.2024.07.006_bib0009","doi-asserted-by":"crossref","first-page":"1","DOI":"10.18103\/mra.v10i9.3136","article-title":"Results from a validated in vitro gastrointestinal model (TIM) used as input data for in silico modeling give highly predictive information for the human situation","volume":"10","author":"Havenaar","year":"2022","journal-title":"Medical Research Archives"},{"issue":"2","key":"10.1016\/j.xphs.2024.07.006_bib0010","doi-asserted-by":"crossref","first-page":"217","DOI":"10.1208\/s12248-009-9098-z","article-title":"Mechanistic approaches to predicting oral drug absorption","volume":"11","author":"Huang","year":"2009","journal-title":"AAPS J"},{"issue":"2","key":"10.1016\/j.xphs.2024.07.006_bib0011","doi-asserted-by":"crossref","first-page":"225","DOI":"10.1208\/s12248-009-9099-y","article-title":"Population-based mechanistic prediction of oral drug absorption","volume":"11","author":"Jamei","year":"2009","journal-title":"AAPS J"},{"key":"10.1016\/j.xphs.2024.07.006_bib0012","doi-asserted-by":"crossref","DOI":"10.3390\/pharmaceutics9040041","article-title":"Predicting oral drug absorption: mini review on physiologically-based pharmacokinetic models","author":"Lin","year":"2017","journal-title":"Pharmaceutics"},{"issue":"9","key":"10.1016\/j.xphs.2024.07.006_bib0013","doi-asserted-by":"crossref","first-page":"2126","DOI":"10.1007\/s11095-016-1951-z","article-title":"Evaluation of the GastroPlus\u2122 advanced compartmental and transit (ACAT) model in early discovery","volume":"33","author":"Gobeau","year":"2016","journal-title":"Pharm Res"},{"issue":"6","key":"10.1016\/j.xphs.2024.07.006_bib0014","doi-asserted-by":"crossref","first-page":"185","DOI":"10.1208\/s12249-022-02343-4","article-title":"Using Tiny-TIM dissolution and in silico simulation to accelerate oral product development of a BCS class II compound","volume":"23","author":"Luo","year":"2022","journal-title":"AAPS PharmSciTech"},{"issue":"2","key":"10.1016\/j.xphs.2024.07.006_bib0015","doi-asserted-by":"crossref","first-page":"101","DOI":"10.1080\/17460441.2022.1995351","article-title":"Discovery, preclinical development, and clinical application of pralsetinib in the treatment of thyroid cancer","volume":"17","author":"Locantore","year":"2022","journal-title":"Expert Opin Drug Discov"},{"key":"10.1016\/j.xphs.2024.07.006_bib0016","unstructured":"2023. Gavreto (pralsetinib) capsules. Highlights of prescribing information. https:\/\/www.gene.com\/download\/pdf\/gavreto_prescribing.pdf (Accessed 30 August 2023)."},{"key":"10.1016\/j.xphs.2024.07.006_bib0017","article-title":"Understanding CYP3A4 and P-gp mediated drug-drug interactions through PBPK modeling - case example of pralsetinib","volume":"29","author":"Bowman","year":"2024","journal-title":"CPT:PSP 2024:Accepted January"},{"key":"10.1016\/j.xphs.2024.07.006_bib0018","doi-asserted-by":"crossref","first-page":"342","DOI":"10.1016\/j.ejps.2013.08.024","article-title":"In vitro models for the prediction of in vivo performance of oral dosage forms","volume":"57","author":"Kostewicz","year":"2014","journal-title":"Eur J Pharmaceut Sci"},{"key":"10.1016\/j.xphs.2024.07.006_bib0019","series-title":"The Impact of Food Bioactives On Health: In Vitro And Ex Vivo Models","first-page":"37","article-title":"The TNO gastro-intestinal model (TIM)","author":"Minekus","year":"2015"},{"issue":"1","key":"10.1016\/j.xphs.2024.07.006_bib0020","doi-asserted-by":"crossref","first-page":"495","DOI":"10.1016\/j.xphs.2017.09.027","article-title":"Mechanistic physiologically based pharmacokinetic modeling of the dissolution and food effect of a biopharmaceutics classification system IV compound\u2014the venetoclax story","volume":"107","author":"Emami Riedmaier","year":"2018","journal-title":"J Pharm Sci"},{"key":"10.1016\/j.xphs.2024.07.006_bib0021","doi-asserted-by":"crossref","first-page":"122","DOI":"10.1016\/j.addr.2016.03.006","article-title":"Physical chemistry of supersaturated solutions and implications for oral absorption","volume":"101","author":"Taylor","year":"2016","journal-title":"Adv Drug Deliv Rev"},{"key":"10.1016\/j.xphs.2024.07.006_bib0022","unstructured":"2020. FDA CDER NDA Multi-discipline review: pralsetinib. https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/nda\/2020\/213721Orig1s000MultidisciplineR.pdf. (Accessed 30 August 2023)."},{"issue":"11","key":"10.1016\/j.xphs.2024.07.006_bib0023","doi-asserted-by":"crossref","first-page":"5416","DOI":"10.1021\/acs.molpharmaceut.3c00422","article-title":"Digitalizing the TIM-1 model using computational approaches\u2013part one: TIM-1 data explorer","volume":"20","author":"Sarcevica","year":"2023","journal-title":"Mol. Pharm"},{"issue":"11","key":"10.1016\/j.xphs.2024.07.006_bib0024","doi-asserted-by":"crossref","first-page":"5429","DOI":"10.1021\/acs.molpharmaceut.3c00423","article-title":"Digitalizing the TIM-1 model using computational approaches\u2013part two: digital TIM-1 model in GastroPlus","volume":"20","author":"Hens","year":"2023","journal-title":"Mol. Pharm"}],"container-title":["Journal of Pharmaceutical Sciences"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0022354924002521?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0022354924002521?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2024,8,31]],"date-time":"2024-08-31T21:57:11Z","timestamp":1725141431000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0022354924002521"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,9]]},"references-count":24,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2024,9]]}},"alternative-id":["S0022354924002521"],"URL":"https:\/\/doi.org\/10.1016\/j.xphs.2024.07.006","relation":{},"ISSN":["0022-3549"],"issn-type":[{"value":"0022-3549","type":"print"}],"subject":[],"published":{"date-parts":[[2024,9]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Integrating Dynamic in vitro Systems and Mechanistic Absorption Modeling: Case Study of Pralsetinib","name":"articletitle","label":"Article Title"},{"value":"Journal of Pharmaceutical Sciences","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.xphs.2024.07.006","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2024 American Pharmacists Association. Published by Elsevier Inc. All rights are reserved, including those for text and data mining, AI training, and similar technologies.","name":"copyright","label":"Copyright"}]}}