{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T17:08:08Z","timestamp":1790096888124,"version":"4.0.1"},"reference-count":39,"publisher":"Elsevier BV","issue":"5","license":[{"start":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T00:00:00Z","timestamp":1788220800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T00:00:00Z","timestamp":1788220800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T00:00:00Z","timestamp":1788220800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-017"},{"start":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T00:00:00Z","timestamp":1788220800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-037"},{"start":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T00:00:00Z","timestamp":1788220800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-012"},{"start":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T00:00:00Z","timestamp":1788220800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-029"},{"start":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T00:00:00Z","timestamp":1788220800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-004"}],"content-domain":{"domain":["elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Drug Discovery Today"],"published-print":{"date-parts":[[2026,9]]},"DOI":"10.1016\/j.drudis.2026.104791","type":"journal-article","created":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T00:22:31Z","timestamp":1788222151000},"page":"104791","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":0,"title":["Exposure Robustness by Design: a translational framework for oral drug product development"],"prefix":"10.1016","volume":"31","author":[{"given":"Muzaffaruddin Ahmed","family":"Madny","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1620-0547","authenticated-orcid":false,"given":"Khushwant S.","family":"Yadav","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1016\/j.drudis.2026.104791_b0005","doi-asserted-by":"crossref","DOI":"10.3389\/fphar.2021.618411","article-title":"Advances in oral drug delivery","volume":"12","author":"Alqahtani","year":"2021","journal-title":"Front Pharmacol"},{"key":"10.1016\/j.drudis.2026.104791_b0010","doi-asserted-by":"crossref","DOI":"10.1016\/j.ejpb.2026.115101","article-title":"The role of pharmaceutical formulation development in clinical trials of new medicinal products","volume":"225","author":"Owczarek","year":"2026","journal-title":"Eur J Pharm Biopharm"},{"key":"10.1016\/j.drudis.2026.104791_b0015","doi-asserted-by":"crossref","first-page":"413","DOI":"10.1023\/A:1016212804288","article-title":"A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability","volume":"12","author":"Amidon","year":"1995","journal-title":"Pharm Res"},{"key":"10.1016\/j.drudis.2026.104791_b0020","series-title":"Exposure\u2013Response Relationships\u2014Study Design, Data Analysis, and Regulatory Applications: Guidance for Industry","author":"US Food and Drug Administration (FDA)","year":"2003"},{"key":"10.1016\/j.drudis.2026.104791_b0025","series-title":"Bioavailability Studies Submitted in NDAs or INDs\u2014General Considerations: Guidance for Industry","author":"US Food and Drug Administration (FDA)","year":"2022"},{"key":"10.1016\/j.drudis.2026.104791_b0030","doi-asserted-by":"crossref","DOI":"10.1016\/j.ejps.2023.106452","article-title":"The impact of advanced age on gastrointestinal characteristics that are relevant to oral drug absorption: an AGePOP review","volume":"187","author":"Stillhart","year":"2023","journal-title":"Eur J Pharm Sci"},{"key":"10.1016\/j.drudis.2026.104791_b0035","doi-asserted-by":"crossref","DOI":"10.1016\/j.ejps.2021.105812","article-title":"Impact of gastrointestinal tract variability on oral drug absorption and pharmacokinetics: an UNGAP review","volume":"162","author":"Vinarov","year":"2021","journal-title":"Eur J Pharm Sci"},{"key":"10.1016\/j.drudis.2026.104791_b0040","doi-asserted-by":"crossref","DOI":"10.1016\/j.dmpk.2022.100488","article-title":"Food effects on gastrointestinal physiology and drug absorption","volume":"48","author":"Kambayashi","year":"2023","journal-title":"Drug Metab Pharmacokinet"},{"key":"10.1016\/j.drudis.2026.104791_b0045","doi-asserted-by":"crossref","DOI":"10.1016\/j.ijpharm.2022.122380","article-title":"Approaches of formulation bridging in support of orally administered drug product development","volume":"629","author":"Han","year":"2022","journal-title":"Int J Pharm"},{"key":"10.1016\/j.drudis.2026.104791_b0050","doi-asserted-by":"crossref","first-page":"793","DOI":"10.1038\/d41573-021-00190-9","article-title":"Clinical development times for innovative drugs","volume":"21","author":"Brown","year":"2022","journal-title":"Nat Rev Drug Discov"},{"key":"10.1016\/j.drudis.2026.104791_b0055","doi-asserted-by":"crossref","first-page":"222","DOI":"10.1016\/j.ejpb.2019.06.010","article-title":"In vivo models and decision trees for formulation development in early drug development: a review of current practices and recommendations for biopharmaceutical development","volume":"142","author":"Zane","year":"2019","journal-title":"Eur J Pharm Biopharm"},{"key":"10.1016\/j.drudis.2026.104791_b0060","doi-asserted-by":"crossref","first-page":"3377","DOI":"10.1002\/jps.24162","article-title":"The biopharmaceutics risk assessment roadmap for optimizing clinical drug product performance","volume":"103","author":"Selen","year":"2014","journal-title":"J Pharm Sci"},{"key":"10.1016\/j.drudis.2026.104791_b0065","doi-asserted-by":"crossref","first-page":"3243","DOI":"10.1016\/j.xphs.2016.07.024","article-title":"Optimizing clinical drug product performance: applying biopharmaceutics risk assessment roadmap (BioRAM) and the BioRAM scoring grid","volume":"105","author":"Dickinson","year":"2016","journal-title":"J Pharm Sci"},{"key":"10.1016\/j.drudis.2026.104791_b0070","doi-asserted-by":"crossref","first-page":"97","DOI":"10.1208\/s12248-020-00470-z","article-title":"Integrated multi-stakeholder systems thinking strategy: decision-making with biopharmaceutics risk assessment roadmap (BioRAM) to optimize clinical performance of drug products","volume":"22","author":"Selen","year":"2020","journal-title":"AAPS J"},{"key":"10.1016\/j.drudis.2026.104791_b0075","doi-asserted-by":"crossref","first-page":"397","DOI":"10.1208\/s12248-010-9203-3","article-title":"The use of biorelevant dissolution media to forecast the in vivo performance of a drug","volume":"12","author":"Klein","year":"2010","journal-title":"AAPS J"},{"key":"10.1016\/j.drudis.2026.104791_b0080","doi-asserted-by":"crossref","first-page":"2065","DOI":"10.1021\/acs.molpharmaceut.4c00202","article-title":"Physiologically based biopharmaceutics modeling (PBBM): best practices for drug product quality, regulatory and industry perspectives: 2023 workshop summary report","volume":"21","author":"Mackie","year":"2024","journal-title":"Mol Pharm"},{"key":"10.1016\/j.drudis.2026.104791_b0085","series-title":"ICH Harmonised Guideline M15: General Principles for Model-Informed Drug Development. Step 5","author":"International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)","year":"2026"},{"key":"10.1016\/j.drudis.2026.104791_b0090","series-title":"Q8(R2) Pharmaceutical Development: Guidance for Industry","author":"ICH","year":"2009"},{"key":"10.1016\/j.drudis.2026.104791_b0095","doi-asserted-by":"crossref","first-page":"1010","DOI":"10.3390\/pharmaceutics14051010","article-title":"Developing clinically relevant dissolution specifications (CRDSs) for oral drug products: virtual webinar series","volume":"14","author":"McAllister","year":"2022","journal-title":"Pharmaceutics"},{"key":"10.1016\/j.drudis.2026.104791_b0100","first-page":"47","article-title":"Comparison of the efficacy of posaconazole delayed release tablets and suspension in pediatric hematology\/oncology patients","volume":"25","author":"Wass","year":"2020","journal-title":"J Pediatr Pharmacol Ther"},{"key":"10.1016\/j.drudis.2026.104791_b0105","first-page":"1","article-title":"Pharmacokinetics and safety of posaconazole delayed-release tablets for invasive fungal infections","volume":"7","author":"Wiederhold","year":"2015","journal-title":"Clin Pharmacol"},{"key":"10.1016\/j.drudis.2026.104791_b0110","doi-asserted-by":"crossref","first-page":"321","DOI":"10.1586\/17512433.2015.1034689","article-title":"Pharmacologic and clinical evaluation of posaconazole","volume":"8","author":"Moore","year":"2015","journal-title":"Expert Rev Clin Pharmacol"},{"key":"10.1016\/j.drudis.2026.104791_b0115","doi-asserted-by":"crossref","first-page":"249","DOI":"10.1007\/s40256-019-00377-x","article-title":"Bioequivalence of a newly developed dabigatran etexilate tablet versus the commercial capsule and impact of rabeprazole-induced elevated gastric pH on exposure in healthy subjects","volume":"20","author":"Harada","year":"2020","journal-title":"Am J Cardiovasc Drugs"},{"key":"10.1016\/j.drudis.2026.104791_b0120","doi-asserted-by":"crossref","first-page":"1294","DOI":"10.1002\/cpdd.1153","article-title":"Bioequivalence and relative bioavailability studies to assess a new acalabrutinib formulation that enables coadministration with proton-pump inhibitors","volume":"11","author":"Sharma","year":"2022","journal-title":"Clin Pharmacol Drug Dev"},{"key":"10.1016\/j.drudis.2026.104791_b0125","series-title":"Clinical Pharmacology and Biopharmaceutics Review(s): NDA 203312, Rytary\u00ae (carbidopa and levodopa) extended-release capsules","author":"US Food and Drug Administration","year":"2014"},{"key":"10.1016\/j.drudis.2026.104791_b0130","series-title":"NDA 217186: Crexont\u00ae (carbidopa and levodopa) Extended-Release Capsules\u2014Product Quality Review","author":"US Food and Drug Administration (FDA)","year":"2023"},{"key":"10.1016\/j.drudis.2026.104791_b0135","doi-asserted-by":"crossref","first-page":"1155","DOI":"10.1002\/jps.23467","article-title":"Pharmacokinetics, efficacy, and tolerability of a once-daily gastroretentive dosage form of gabapentin for the treatment of postherpetic neuralgia","volume":"102","author":"Chen","year":"2013","journal-title":"J Pharm Sci"},{"key":"10.1016\/j.drudis.2026.104791_b0140","doi-asserted-by":"crossref","first-page":"16502","DOI":"10.1038\/s41598-023-43755-x","article-title":"Association of high intra-patient variability in tacrolimus exposure with calcineurin inhibitor nephrotoxicity in kidney transplantation","volume":"13","author":"Kim","year":"2023","journal-title":"Sci Rep"},{"key":"10.1016\/j.drudis.2026.104791_b0145","doi-asserted-by":"crossref","DOI":"10.3389\/fphar.2023.1310339","article-title":"Comparison of a novel tablet formulation of tacrolimus and conventional capsule formulation in de novo kidney transplant recipients: a systematic review and meta-analysis","volume":"14","author":"Liu","year":"2023","journal-title":"Front Pharmacol"},{"key":"10.1016\/j.drudis.2026.104791_b0150","doi-asserted-by":"crossref","first-page":"938","DOI":"10.1046\/j.1523-1755.1998.00042.x","article-title":"Cyclosporine microemulsion increases drug exposure and reduces acute rejection without incremental toxicity in de novo renal transplantation","volume":"54","author":"Keown","year":"1998","journal-title":"Kidney Int"},{"key":"10.1016\/j.drudis.2026.104791_b0155","doi-asserted-by":"crossref","first-page":"1456","DOI":"10.1016\/j.clinthera.2004.09.015","article-title":"A new fenofibrate formulation: results of six single-dose clinical studies of bioavailability under fed and fasting conditions","volume":"26","author":"Guivarch","year":"2004","journal-title":"Clin Ther"},{"key":"10.1016\/j.drudis.2026.104791_b0160","doi-asserted-by":"crossref","first-page":"207","DOI":"10.1002\/cpdd.1019","article-title":"Pharmacokinetics of asciminib when taken with imatinib or with food","volume":"11","author":"Hoch","year":"2022","journal-title":"Clin Pharmacol Drug Dev"},{"key":"10.1016\/j.drudis.2026.104791_b0165","doi-asserted-by":"crossref","first-page":"4192","DOI":"10.1021\/acs.molpharmaceut.7b00198","article-title":"Validation of dissolution testing with biorelevant media: an OrBiTo study","volume":"14","author":"Mann","year":"2017","journal-title":"Mol Pharm"},{"key":"10.1016\/j.drudis.2026.104791_b0170","doi-asserted-by":"crossref","first-page":"586","DOI":"10.1021\/acs.molpharmaceut.5b00808","article-title":"Development of a unified dissolution and precipitation model and its use for the prediction of oral drug absorption","volume":"13","author":"Jakubiak","year":"2016","journal-title":"Mol Pharm"},{"key":"10.1016\/j.drudis.2026.104791_b0175","doi-asserted-by":"crossref","first-page":"2940","DOI":"10.1016\/j.xphs.2024.06.014","article-title":"A stratified analysis of supersaturation and precipitation effects based on the refined developability classification system (rDCS)","volume":"113","author":"Beran","year":"2024","journal-title":"J Pharm Sci"},{"key":"10.1016\/j.drudis.2026.104791_b0180","doi-asserted-by":"crossref","first-page":"108","DOI":"10.1208\/s12249-022-02264-2","article-title":"Physiologically based biopharmaceutics model of vildagliptin modified release (MR) tablets to predict in vivo performance and establish clinically relevant dissolution specifications","volume":"23","author":"Madny","year":"2022","journal-title":"AAPS PharmSciTech"},{"key":"10.1016\/j.drudis.2026.104791_b0185","doi-asserted-by":"crossref","first-page":"375","DOI":"10.1007\/s11095-022-03268-0","article-title":"Physiologically based absorption modelling to explore the formulation and gastric pH changes on the pharmacokinetics of acalabrutinib","volume":"40","author":"Zhou","year":"2023","journal-title":"Pharm Res"},{"key":"10.1016\/j.drudis.2026.104791_b0190","doi-asserted-by":"crossref","first-page":"421","DOI":"10.1016\/j.ejpb.2019.07.014","article-title":"Bridging in vitro dissolution and in vivo exposure for acalabrutinib. Part I. Mechanistic modelling of drug product dissolution to derive a P-PSD for PBPK model input","volume":"142","author":"Pepin","year":"2019","journal-title":"Eur J Pharm Biopharm"},{"key":"10.1016\/j.drudis.2026.104791_b0195","doi-asserted-by":"crossref","first-page":"1266","DOI":"10.3390\/pharmaceutics17101266","article-title":"Physiologically based pharmacokinetic modeling and simulations in lieu of clinical pharmacology studies to support the new drug application of asciminib","volume":"17","author":"Loisios-Konstantinidis","year":"2025","journal-title":"Pharmaceutics"}],"container-title":["Drug Discovery Today"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1359644626001960?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1359644626001960?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T16:14:39Z","timestamp":1790093679000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S1359644626001960"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9]]},"references-count":39,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2026,9]]}},"alternative-id":["S1359644626001960"],"URL":"https:\/\/doi.org\/10.1016\/j.drudis.2026.104791","relation":{},"ISSN":["1359-6446"],"issn-type":[{"value":"1359-6446","type":"print"}],"subject":[],"published":{"date-parts":[[2026,9]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Exposure Robustness by Design: a translational framework for oral drug product development","name":"articletitle","label":"Article Title"},{"value":"Drug Discovery Today","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.drudis.2026.104791","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2026 Elsevier Ltd. All rights are reserved, including those for text and data mining, AI training, and similar technologies.","name":"copyright","label":"Copyright"}],"article-number":"104791"}}