IMI – oral biopharmaceutics tools project – evaluation of bottom-up PBPK prediction success part 1: Characterisation of the OrBiTo database of compounds

A Theoretical Basis for a Biopharmaceutic Drug Classification: The Correlation of in Vitro Drug Product Dissolution and in Vivo Bioavailability

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Molecular Properties of WHO Essential Drugs and Provisional Biopharmaceutical Classification

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Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System

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BDDCS Applied to Over 900 Drugs

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Trend Analysis of a Database of Intravenous Pharmacokinetic Parameters in Humans for 670 Drug Compounds

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A compartmental absorption and transit model for estimating oral drug absorption

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A Novel Strategy for Physiologically Based Predictions of Human Pharmacokinetics

Jones, H. M., Parrott, N., Jorga, K., & Lav??, T. (2006) · Clinical Pharmacokinetics · doi:10.2165/00003088-200645050-00006 · Cited by 352 · see citing works

PBPK models for the prediction of in vivo performance of oral dosage forms

Kostewicz, E. S., Aarons, L. J., Bergstrand, M., Bolger, M. B., Galetin, A., Hatley, O. J. D., Jamei, M., Lloyd, R. S., Pepin, X. J. H., Rostami‐Hodjegan, A., et al. (2013) · European Journal of Pharmaceutical Sciences · doi:10.1016/j.ejps.2013.09.008 · Cited by 316 · see citing works

Prediction of Human Pharmacokinetics from Preclinical Information: Comparative Accuracy of Quantitative Prediction Approaches

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Prediction of human pharmacokinetics using physiologically based modeling: a retrospective analysis of 26 clinically tested drugs

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Renewal of the epithelium in the descending colon of the mouse. I. Presence of three cell populations: vacuolated-columnar, mucous and argentaffin

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The utility of modeling and simulation in drug development and regulatory review

Huang, S.-M., Abernethy, D. R., Wang, Y., Zhao, P., & Zineh, I. (2013) · Journal of Pharmaceutical Sciences · doi:10.1002/jps.23570 · Cited by 206 · see citing works

Jejunal Permeability: A Comparison Between the Ussing Chamber Technique and the Single-Pass Perfusion in Humans

Lennernäs, H., Nylander, S., & Ungell, A. ‐. (1997) · Pharmaceutical Research · doi:10.1023/a:1012121632357 · Cited by 173 · see citing works

Prediction of intestinal absorption: comparative assessment of gastroplus™ and idea™

Parrott, N., & Lavé, T. (2002) · European Journal of Pharmaceutical Sciences · doi:10.1016/s0928-0987(02)00132-x · Cited by 170 · see citing works

In silico predictions of gastrointestinal drug absorption in pharmaceutical product development: application of the mechanistic absorption model GI-Sim

Sjögren, E., Westergren, J., Grant, I., Hanisch, G., Lindfors, L., Lennernäs, H., Abrahamsson, B., & Tannergren, C. (2013) · European Journal of Pharmaceutical Sciences · doi:10.1016/j.ejps.2013.05.019 · Cited by 168 · see citing works

Simulation of Human Intravenous and Oral Pharmacokinetics of 21 Diverse Compounds Using Physiologically Based Pharmacokinetic Modelling

Jones, H. M., Gardner, I. B., Collard, W. T., Stanley, P. J., Oxley, P., Hosea, N. A., Plowchalk, D., Gernhardt, S., Lin, J., Dickins, M., et al. (2011) · Clinical Pharmacokinetics · doi:10.2165/11539680-000000000-00000 · Cited by 110 · see citing works

Oral biopharmaceutics tools – Time for a new initiative – An introduction to the IMI project OrBiTo

Lennernäs, H., Aarons, L. J., Augustijns, P., Beato, S., Bolger, M. B., Box, K. J., Brewster, M. E., Butler, J., Dressman, J., Holm, R., et al. (2013) · European Journal of Pharmaceutical Sciences · doi:10.1016/j.ejps.2013.10.012 · Cited by 100 · see citing works

A Literature Review of Enzyme Kinetic Parameters for CYP3A4-Mediated Metabolic Reactions of 113 Drugs in Human Liver Microsomes: Structure- Kinetics Relationship Assessment

Bu, H. (2006) · Current Drug Metabolism · doi:10.2174/138920006776359329 · Cited by 86 · see citing works

The effect of ketoconazole on the in vivo intestinal permeability of fexofenadine using a regional perfusion technique

Tannergren, C., Knutson, T. W., Knutson, L., & Lennernäs, H. (2003) · British Journal of Clinical Pharmacology · doi:10.1046/j.1365-2125.2003.01722.x · Cited by 74 · see citing works

PhRMA CPCDC Initiative on Predictive Models of Human Pharmacokinetics, Part 1: Goals, Properties of the Phrma Dataset, and Comparison with Literature Datasets

Poulin, P., Jones, H. M., Jones, R. D. O., Yates, J. W. T., Gibson, C. R., Chien, J. Y., Ring, B. J., Adkison, K. K., He, H., Vuppugalla, R., et al. (2011) · Journal of Pharmaceutical Sciences · doi:10.1002/jps.22554 · Cited by 62 · see citing works

Effects of a d -Xylose Preload With or Without Sitagliptin on Gastric Emptying, Glucagon-Like Peptide-1, and Postprandial Glycemia in Type 2 Diabetes

Wu, T., Bound, M. J., Zhao, B. R., Standfield, S., Bellon, M., Jones, K. L., Horowitz, M., & Rayner, C. K. (2013) · Diabetes Care · doi:10.2337/dc12-2294 · Cited by 58 · see citing works

Molecular weight of barley β-glucan influences energy expenditure, gastric emptying and glycaemic response in human subjects

Thondre, P. S., Shafat, A., & Clegg, M. E. (2013) · British Journal Of Nutrition · doi:10.1017/s0007114513001682 · Cited by 57 · see citing works

Microdosing: A Critical Assessment of Human Data

Rowland, M. (2012) · Journal of Pharmaceutical Sciences · doi:10.1002/jps.23290 · Cited by 54 · see citing works

Quantitative prediction of formulation-specific food effects and their population variability from in vitro data with the physiologically-based ADAM model: A case study using the BCS/BDDCS Class II drug nifedipine

Patel, N. K., Polak, S., Jamei, M., Rostami‐Hodjegan, A., & Turner, D. B. (2013) · European Journal of Pharmaceutical Sciences · doi:10.1016/j.ejps.2013.09.006 · Cited by 44 · see citing works

Impact of sleep disorders in J apanese patients with functional dyspepsia ( FD ): Nizatidine improves clinical symptoms, gastric emptying and sleep disorders in FD patients

Futagami, S., Yamawaki, H., Izumi, N., Shimpuku, M., Kodaka, Y., Wakabayashi, T., Nagoya, H., Shindo, T., Kawagoe, T., Gudis, K., et al. (2013) · Journal of Gastroenterology and Hepatology · doi:10.1111/jgh.12236 · Cited by 33 · see citing works

Intestinal Permeability and Drug Absorption: Predictive Experimental, Computational and In Vivo Approaches

Dahlgren, D., & Lennernäs, H. (2019) · Pharmaceutics · doi:10.3390/pharmaceutics11080411 · Cited by 261 · see citing works

Physiologically Based Pharmacokinetic Modelling for First-In-Human Predictions: An Updated Model Building Strategy Illustrated with Challenging Industry Case Studies

Miller, N. A., Reddy, M. B., Heikkinen, A. T., Lukacova, V., & Parrott, N. (2019) · Clinical Pharmacokinetics · doi:10.1007/s40262-019-00741-9 · Cited by 142 · see citing works

Model-Based Analysis of Biopharmaceutic Experiments To Improve Mechanistic Oral Absorption Modeling: An Integrated in Vitro in Vivo Extrapolation Perspective Using Ketoconazole as a Model Drug

Pathak, S. M., Ruff, A., Kostewicz, E. S., Patel, N. K., Turner, D. B., & Jamei, M. (2017) · Molecular Pharmaceutics · doi:10.1021/acs.molpharmaceut.7b00406 · Cited by 97 · see citing works

IMI - Oral biopharmaceutics tools project - Evaluation of bottom-up PBPK prediction success part 2: An introduction to the simulation exercise and overview of results

Margolskee, A., Darwich, A. S., Pepin, X., Aarons, L., Galetin, A., Rostami-Hodjegan, A., Carlert, S., Hammarberg, M., Hilgendorf, C., Johansson, P., et al. (2017) · European Journal of Pharmaceutical Sciences · doi:10.1016/j.ejps.2016.10.036 · Cited by 69 · see citing works

Fasted and fed state human duodenal fluids: Characterization, drug solubility, and comparison to simulated fluids and with human bioavailability

Dahlgren, D., Venczel, M., Ridoux, J.-P., Skjöld, C., Müllertz, A., Holm, R., Augustijns, P., Hellström, P. M., & Lennernäs, H. (2021) · European Journal of Pharmaceutics and Biopharmaceutics · doi:10.1016/j.ejpb.2021.04.005 · Cited by 62 · see citing works

Evaluation of the Success of High-Throughput Physiologically Based Pharmacokinetic (HT-PBPK) Modeling Predictions to Inform Early Drug Discovery

Naga, D., Parrott, N. J., Ecker, G. F., & Olivares‐Morales, A. (2022) · Molecular Pharmaceutics · doi:10.1021/acs.molpharmaceut.2c00040 · Cited by 62 · see citing works

IMI – Oral biopharmaceutics tools project – Evaluation of bottom-up PBPK prediction success part 3: Identifying gaps in system parameters by analysing In Silico performance across different compound classes

Darwich, A. S., Margolskee, A., Pepin, X., Aarons, L., Galetin, A., Rostami-Hodjegan, A., Carlert, S., Hammarberg, M., Hilgendorf, C., Johansson, P., et al. (2017) · European Journal of Pharmaceutical Sciences · doi:10.1016/j.ejps.2016.09.037 · Cited by 45 · see citing works

A Retrospective Biopharmaceutical Analysis of >800 Approved Oral Drug Products: Are Drug Properties of Solid Dispersions and Lipid-Based Formulations Distinctive?

Bennett-Lenane, H., O’Shea, J. P., O’Driscoll, C. M., & Griffin, B. T. (2020) · Journal of Pharmaceutical Sciences · doi:10.1016/j.xphs.2020.08.008 · Cited by 37 · see citing works

The BioGIT System: a Valuable In Vitro Tool to Assess the Impact of Dose and Formulation on Early Exposure to Low Solubility Drugs After Oral Administration

Kourentas, A., Vertzoni, M., Barmpatsalou, V., Augustijns, P., Beato, S., Butler, J., Holm, R., Ouwerkerk, N., Rosenberg, J., Tajiri, T., et al. (2018) · The AAPS Journal · doi:10.1208/s12248-018-0231-8 · Cited by 36 · see citing works

Regional Proteomic Quantification of Clinically Relevant Non-Cytochrome P450 Enzymes along the Human Small Intestine

Zhang, H., Wolford, C., Basit, A., Li, A. P., Fan, P. W., Murray, B. P., Takahashi, R., Khojasteh, S. C., Smith, B. J., Thummel, K. E., et al. (2020) · Drug Metabolism and Disposition · doi:10.1124/dmd.120.090738 · Cited by 36 · see citing works

Bottom-Up Physiologically Based Oral Absorption Modeling of Free Weak Base Drugs

Matsumura, N., Ono, A., Akiyama, Y., Fujita, T., & Sugano, K. (2020) · Pharmaceutics · doi:10.3390/pharmaceutics12090844 · Cited by 34 · see citing works

Exploring impact of supersaturated lipid-based drug delivery systems of celecoxib on in vitro permeation across PermeapadⓇ membrane and in vivo absorption

Ilie, A.-R., Griffin, B. T., Brandl, M., Bauer-Brandl, A., Jacobsen, A.-C., Vertzoni, M., Kuentz, M., Kolakovic, R., & Holm, R. (2020) · European Journal of Pharmaceutical Sciences · doi:10.1016/j.ejps.2020.105452 · Cited by 33 · see citing works

Quantitative Translational Modeling to Facilitate Preclinical to Clinical Efficacy & Toxicity Translation in Oncology

Zhu, A. (2018) · Future Science OA · doi:10.4155/fsoa-2017-0152 · Cited by 33 · see citing works

ICH M9 Guideline in Development on Biopharmaceutics Classification System-Based Biowaivers: An Industrial Perspective from the IQ Consortium

Bransford, P., Cook, J., Gupta, M., Haertter, S., He, H., Ju, R., Kanodia, J., Lennernäs, H., Lindley, D., Polli, J. E., et al. (2019) · Molecular Pharmaceutics · doi:10.1021/acs.molpharmaceut.9b01062 · Cited by 33 · see citing works

Perspectives for systems biology in the management of tuberculosis

Kontsevaya, I., Lange, C. G., Comella-del-Barrio, P., Coarfa, C., DiNardo, A. R., Gillespie, S. H., Hauptmann, M., Leschczyk, C., Mandalakas, A. M., Martinecz, A., et al. (2021) · European Respiratory Review · doi:10.1183/16000617.0377-2020 · Cited by 31 · see citing works

Prediction Characteristics of Oral Absorption Simulation Software Evaluated Using Structurally Diverse Low-Solubility Drugs

Matsumura, N., Hayashi, S., Akiyama, Y., Ono, A., Funaki, S., Tamura, N., Kimoto, T., Jiko, M., Haruna, Y., Sarashina, A., et al. (2019) · Journal of Pharmaceutical Sciences · doi:10.1016/j.xphs.2019.12.009 · Cited by 29 · see citing works

Six years of progress in the oral biopharmaceutics area – A summary from the IMI OrBiTo project

Abrahamsson, B., McAllister, M. S., Augustijns, P., Zane, P. A., Butler, J., Holm, R., Langguth, P., Lindahl, A. H., Müllertz, A., Pepin, X. J. H., et al. (2020) · European Journal of Pharmaceutics and Biopharmaceutics · doi:10.1016/j.ejpb.2020.05.008 · Cited by 28 · see citing works

Global Sensitivity Analysis of the Rodgers and Rowland Model for Prediction of Tissue: Plasma Partitioning Coefficients: Assessment of the Key Physiological and Physicochemical Factors That Determine Small-Molecule Tissue Distribution

Yau, E., Olivares‐Morales, A., Gertz, M., Parrott, N. J., Darwich, A. S., Aarons, L. J., & Ogungbenro, K. (2020) · The AAPS Journal · doi:10.1208/s12248-020-0418-7 · Cited by 28 · see citing works

Advances in In Vivo Predictive Dissolution Testing of Solid Oral Formulations: How Closer to In Vivo Performance?

Shrivas, M., Khunt, D., Shrivas, M., Choudhari, M. V., Rathod, R., & Misra, M. (2019) · Journal of Pharmaceutical Innovation · doi:10.1007/s12247-019-09392-6 · Cited by 25 · see citing works

Model-Informed Drug Discovery and Development Strategy for the Rapid Development of Anti-Tuberculosis Drug Combinations

van Wijk, R. C., Alsoud, R. A., Lennernäs, H., & Simonsson, U. S. H. (2020) · Applied Sciences · doi:10.3390/app10072376 · Cited by 20 · see citing works

Physiologically Based Pharmacokinetic Modeling to Evaluate Formulation Factors Influencing Bioequivalence of Metoprolol Extended‐Release Products

Basu, S., Yang, H., Fang, L., González‐Sales, M., Zhao, L. Y., Trame, M. N., Lesko, L. J., & Schmidt, S. (2019) · The Journal of Clinical Pharmacology · doi:10.1002/jcph.1017 · Cited by 19 · see citing works

Performance evaluation of the GastroPlusTM software tool for prediction of the toxicokinetic parameters of chemicals

Zhang, F., Bartels, M., Clark, A. J., Erskine, T., Auernhammer, T. R., Bhhatarai, B., Wilson, D., & Marty, S. (2018) · SAR and QSAR in environmental research · doi:10.1080/1062936x.2018.1518928 · Cited by 18 · see citing works

Bottom-up physiologically-based biokinetic modelling as an alternative to animal testing

Chan, J. (2019) · ALTEX · doi:10.14573/altex.1812051 · Cited by 17 · see citing works

Preclinical Bioavailability Strategy for Decisions on Clinical Drug Formulation Development: An In Depth Analysis

den Bergh, A. V., Hemelryck, S. V., Bevernage, J., Peer, A. V., Brewster, M. E., Mackie, C. E., & Mannaert, E. (2018) · Molecular Pharmaceutics · doi:10.1021/acs.molpharmaceut.8b00172 · Cited by 16 · see citing works

Variance based global sensitivity analysis of physiologically based pharmacokinetic absorption models for BCS I–IV drugs

Melillo, N., Aarons, L. J., Magni, P., & Darwich, A. S. (2018) · Journal of Pharmacokinetics and Pharmacodynamics · doi:10.1007/s10928-018-9615-8 · Cited by 14 · see citing works

Population variability in animal health: Influence on dose‐exposure‐response relationships: Part II : Modelling and simulation

Martinez, M. N., Gehring, R., Mochel, J. P., Pade, D., & Pelligand, L. (2018) · Journal of Veterinary Pharmacology and Therapeutics · doi:10.1111/jvp.12666 · Cited by 13 · see citing works

The ADME profile of the fungicide tricyclazole in rodent via the oral route: A critical review for human health safety assessment

Corvaro, M., & Bartels, M. J. (2019) · Regulatory Toxicology and Pharmacology · doi:10.1016/j.yrtph.2019.104438 · Cited by 12 · see citing works

Forecasting gastrointestinal precipitation and oral pharmacokinetics of dantrolene in dogs using an in vitro precipitation testing coupled with in silico modeling and simulation

Kambayashi, A., & Dressman, J. (2017) · European Journal of Pharmaceutics and Biopharmaceutics · doi:10.1016/j.ejpb.2017.06.012 · Cited by 11 · see citing works

A public–private partnership to enrich the development of in silico predictive models for pharmacokinetic and cardiotoxic properties

Komura, H., Watanabe, R., Kawashima, H., Ohashi, R., Kuroda, M., Sato, T., Honma, T., & Mizuguchi, K. (2021) · Drug Discovery Today · doi:10.1016/j.drudis.2021.01.024 · Cited by 11 · see citing works

An IQ Consortium Perspective on Connecting Dissolution Methods to In Vivo Performance: Analysis of an Industrial Database and Case Studies to Propose a Workflow

Aburub, A., Chen, Y., Chung, J., Gao, P., Good, D., Hansmann, S., Hawley, M., Heimbach, T., Hingle, M., Kesisoglou, F., et al. (2022) · The AAPS Journal · doi:10.1208/s12248-022-00699-w · Cited by 9 · see citing works

Improving on in-silico prediction of oral drug bioavailability

Alqahtani, S. (2023) · Expert Opinion on Drug Metabolism & Toxicology · doi:10.1080/17425255.2023.2261366 · Cited by 8 · see citing works

Digitalizing the TIM-1 Model using Computational Approaches–Part One: TIM-1 Data Explorer

Sarceviča, I., Hens, B., Tomaszewska, I., & McAllister, M. S. (2023) · Molecular Pharmaceutics · doi:10.1021/acs.molpharmaceut.3c00422 · Cited by 7 · see citing works

The Use of Global Sensitivity Analysis to Assess the Oral Absorption of Weakly Basic Compounds: A Case Example of Dipyridamole

Kesharwani, S. S., Louit, G., & Ibrahim, F. (2024) · Pharmaceutical Research · doi:10.1007/s11095-024-03688-0 · Cited by 7 · see citing works

The tangential flow absorption model (TFAM) – A novel dissolution method for evaluating the performance of amorphous solid dispersions of poorly water-soluble actives

Haering, B., Seyferth, S., & Schiffter, H. A. (2020) · European Journal of Pharmaceutics and Biopharmaceutics · doi:10.1016/j.ejpb.2020.06.013 · Cited by 6 · see citing works

Determinants of Intestinal Availability for P-glycoprotein Substrate Drugs Estimated by Extensive Simulation With Mathematical Absorption Models

Ando, H., Hatakeyama, H., Sato, H., Hisaka, A., & Suzuki, H. (2017) · Journal of Pharmaceutical Sciences · doi:10.1016/j.xphs.2017.04.065 · Cited by 6 · see citing works

Revisiting the role of gut wall in the fate of orally administered drugs: Why now and to what effect?

Rostami‐Hodjegan, A., Tamai, I., & Pang, K. S. (2017) · Biopharmaceutics & Drug Disposition · doi:10.1002/bdd.2071 · Cited by 4 · see citing works

A structured oral formulation database for machine learning: Uncovering data-informed design strategies to facilitate effective formulation development

Zhou, J., Li, C., Zan, P., Wang, Z. D., Wang, B., Zhao, Y., Gao, X., & Zheng, A. (2026) · International Journal of Pharmaceutics · doi:10.1016/j.ijpharm.2026.126957 · Cited by 3 · see citing works

Role of Pharmacokinetics and Pharmacokinetic Modeling in Drug Development

Arnold, S. L. M., & Isoherranen, N. (2021) · Elsevier eBooks · doi:10.1016/b978-0-12-820472-6.00066-9 · Cited by 2 · see citing works

Blending techniques and formulation strategies

Chacko, I. A., Ramachandran, G., & Sudheesh, M. S. (2024) · Elsevier eBooks · doi:10.1016/b978-0-323-95233-0.00003-0 · Cited by 1 · see citing works

Unlocking the Mystery(ies) While Predicting Bioavailability from Dissolution

Banakar, U. V. (2022) · Wiley eBooks · doi:10.1002/9781119634645.ch19

Bottom-up physiologically-based biokinetic modelling as an alternative to animal testing_suppl

Chan, J. C. Y. (2019) · ALTEX · doi:10.14573/altex.1812051s

Prediction of Human Drug-Drug InteractionsPreprint

Simonsson, U. S. H. (2020) · doi:10.32545/encyclopedia202004.0012.v1

Determinant Factors for Passive Absorption of Drugs

Zhu, W., & Milewski, M. (2023) · Wiley eBooks · doi:10.1002/9781119660699.ch6

IMI - Oral biopharmaceutics tools project - Evaluation of bottom-up PBPK prediction success part 2: An introduction to the simulation exercise and overview of results

Margolskee, A., Darwich, A. S., Pepin, X., Aarons, L., Galetin, A., Rostami-Hodjegan, A., Carlert, S., Hammarberg, M., Hilgendorf, C., Johansson, P., et al. (2017) · European Journal of Pharmaceutical Sciences · doi:10.1016/j.ejps.2016.10.036 · Cited by 69 · see citing works

IMI – Oral biopharmaceutics tools project – Evaluation of bottom-up PBPK prediction success part 3: Identifying gaps in system parameters by analysing In Silico performance across different compound classes

Darwich, A. S., Margolskee, A., Pepin, X., Aarons, L., Galetin, A., Rostami-Hodjegan, A., Carlert, S., Hammarberg, M., Hilgendorf, C., Johansson, P., et al. (2017) · European Journal of Pharmaceutical Sciences · doi:10.1016/j.ejps.2016.09.037 · Cited by 45 · see citing works

Exploring impact of supersaturated lipid-based drug delivery systems of celecoxib on in vitro permeation across PermeapadⓇ membrane and in vivo absorption

Ilie, A.-R., Griffin, B. T., Brandl, M., Bauer-Brandl, A., Jacobsen, A.-C., Vertzoni, M., Kuentz, M., Kolakovic, R., & Holm, R. (2020) · European Journal of Pharmaceutical Sciences · doi:10.1016/j.ejps.2020.105452 · Cited by 33 · see citing works

Forecasting oral absorption across biopharmaceutics classification system classes with physiologically based pharmacokinetic models

Hansmann, S., Darwich, A., Margolskee, A., Aarons, L., & Dressman, J. (2016) · Journal of Pharmacy and Pharmacology · doi:10.1111/jphp.12618 · Cited by 38 · see citing works

Predicting Oral Drug Absorption: Mini Review on Physiologically-Based Pharmacokinetic Models

Lin, L., & Wong, H. (2017) · Pharmaceutics · doi:10.3390/pharmaceutics9040041 · Cited by 172 · see citing works