Recent Advances in Development and Application of Physiologically-Based Pharmacokinetic (PBPK) Models: a Transition from Academic Curiosity to Regulatory Acceptance

Physiologically based pharmacokinetic modelling 2: Predicting the tissue distribution of acids, very weak bases, neutrals and zwitterions

Rodgers, T., & Rowland, M. (2006) · Journal of Pharmaceutical Sciences · doi:10.1002/jps.20502 · Cited by 949 · see citing works

Physiologically-Based Pharmacokinetics in Drug Development and Regulatory Science

Rowland, M., Peck, C., & Tucker, G. (2011) · Annual Review of Pharmacology and Toxicology · doi:10.1146/annurev-pharmtox-010510-100540 · Cited by 662 · see citing works

Simulation and prediction of in vivo drug metabolism in human populations from in vitro data

Rostami‐Hodjegan, A., & Tucker, G. T. (2007) · Nature Reviews Drug Discovery · doi:10.1038/nrd2173 · Cited by 533 · see citing works

Applications of Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulation During Regulatory Review

Zhao, P., Zhang, L., Grillo, J. A., Liu, Q., Bullock, J. M., Moon, Y. J., Song, P., Brar, S. S., Madabushi, R., Wu, T. C., et al. (2010) · Clinical Pharmacology & Therapeutics · doi:10.1038/clpt.2010.298 · Cited by 524 · see citing works

Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulation Approaches: A Systematic Review of Published Models, Applications, and Model Verification

Sager, J. E., Yu, J., Ragueneau, I., & Isoherranen, N. (2015) · Drug Metabolism and Disposition · doi:10.1124/dmd.115.065920 · Cited by 521 · see citing works

Physiologically based pharmacokinetic modeling in drug discovery and development: A pharmaceutical industry perspective

Jones, H., Chen, Y., Gibson, C., Heimbach, T., Parrott, N., Peters, S., Snoeys, J., Upreti, V., Zheng, M., & Hall, S. (2015) · Clinical Pharmacology & Therapeutics · doi:10.1002/cpt.37 · Cited by 488 · see citing works

A Framework for Assessing Inter-individual Variability in Pharmacokinetics Using Virtual Human Populations and Integrating General Knowledge of Physical Chemistry, Biology, Anatomy, Physiology and Genetics: A Tale of ‘Bottom-Up’ vs ‘Top-Down’ Recognition of Covariates

Jamei, M., Dickinson, G. L., & Rostami‐Hodjegan, A. (2009) · Drug Metabolism and Pharmacokinetics · doi:10.2133/dmpk.24.53 · Cited by 368 · see citing works

Physiologically Based Pharmacokinetics Joined with In Vitro–In Vivo Extrapolation of ADME: A Marriage Under the Arch of Systems Pharmacology

Rostami-Hodjegan, A. (2012) · Clinical Pharmacology & Therapeutics · doi:10.1038/clpt.2012.65 · Cited by 331 · see citing works

Prediction of Pharmacokinetics Prior to In Vivo Studies. II. Generic Physiologically Based Pharmacokinetic Models of Drug Disposition

Poulin, P., & Theil, F. (2002) · Journal of Pharmaceutical Sciences · doi:10.1002/jps.10128 · Cited by 303 · see citing works

Application of physiologically based pharmacokinetic (PBPK) modeling to support dose selection: report of an FDA public workshop on PBPK

Wagner, C., Zhao, P., Pan, Y., Hsu, V, Grillo, J., Huang, S., & Sinha, V (2015) · CPT: Pharmacometrics & Systems Pharmacology · doi:10.1002/psp4.33 · Cited by 276 · see citing works

Combining the ‘bottom up’ and ‘top down’ approaches in pharmacokinetic modelling: fitting PBPK models to observed clinical data

Tsamandouras, N., Rostami‐Hodjegan, A., & Aarons, L. J. (2013) · British Journal of Clinical Pharmacology · doi:10.1111/bcp.12234 · Cited by 251 · see citing works

Best Practice in the Use of Physiologically Based Pharmacokinetic Modeling and Simulation to Address Clinical Pharmacology Regulatory Questions

Zhao, P., Rowland, M., & Sm, H. (2012) · Clinical Pharmacology & Therapeutics · doi:10.1038/clpt.2012.68 · Cited by 213 · see citing works

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

Regulatory Experience With Physiologically Based Pharmacokinetic Modeling for Pediatric Drug Trials

Leong, R., Vieira, M. L. T., Zhao, P., Mulugeta, Y. A., Lee, C. S., Sm, H., & Burckart, G. J. (2012) · Clinical Pharmacology & Therapeutics · doi:10.1038/clpt.2012.19 · Cited by 188 · see citing works

Resurgence in the use of physiologically based pharmacokinetic models in pediatric clinical pharmacology: parallel shift in incorporating the knowledge of biological elements and increased applicability to drug development and clinical practice

Johnson, T., & Rostami-Hodjegan, A. (2011) · Paediatric anaesthesia · doi:10.1111/j.1460-9592.2010.03323.x · Cited by 173 · see citing works

The Role of Physiologically Based Pharmacokinetic Modeling in Regulatory Review

Huang, S.-M., & Rowland, M. (2012) · Clinical Pharmacology & Therapeutics · doi:10.1038/clpt.2011.320 · Cited by 150 · cited 1× · see citing works

Predicting the effect of cytochrome P450 inhibitors on substrate drugs: Analysis of physiologically based pharmacokinetic modeling submissions to the US Food and Drug Administration

Wagner, C., Pan, Y., Hsu, V., Grillo, J. A., Zhang, L., Reynolds, K. S., Sinha, V., & Zhao, P. (2015) · Clinical Pharmacokinetics · doi:10.1007/s40262-014-0188-4 · Cited by 148 · see citing works

Physiologically based pharmacokinetic (PBPK) modelling tools: how to fit with our needs?

Bouzom, F., Ball, K., Perdaems, N., & Walther, B. (2012) · Biopharmaceutics & Drug Disposition · doi:10.1002/bdd.1767 · Cited by 99 · see citing works

Predicting the Effect of CYP3A Inducers on the Pharmacokinetics of Substrate Drugs Using Physiologically Based Pharmacokinetic (PBPK) Modeling: An Analysis of PBPK Submissions to the US FDA

Wagner, C., Pan, Y., Hsu, V., Sinha, V. P., & Zhao, P. (2015) · Clinical Pharmacokinetics · doi:10.1007/s40262-015-0330-y · Cited by 91 · see citing works

Changes in Individual Drug-Independent System Parameters during Virtual Paediatric Pharmacokinetic Trials: Introducing Time-Varying Physiology into a Paediatric PBPK Model

Abduljalil, K., Jamei, M., Rostami‐Hodjegan, A., & Johnson, T. N. (2014) · The AAPS Journal · doi:10.1208/s12248-014-9592-9 · Cited by 88 · see citing works

Towards Quantitation of the Effects of Renal Impairment and Probenecid Inhibition on Kidney Uptake and Efflux Transporters, Using Physiologically Based Pharmacokinetic Modelling and Simulations

Hsu, V., Vieira, M. D. L. T., Zhao, P., Zhang, L., Zheng, J., Nordmark, A., Berglund, E. G., Giacomini, K. M., & Huang, S. M. (2013) · Clinical Pharmacokinetics · doi:10.1007/s40262-013-0117-y · Cited by 85 · see citing works

Development of a Multicompartment Permeability‐Limited Lung PBPK Model and Its Application in Predicting Pulmonary Pharmacokinetics of Antituberculosis Drugs

Gaohua, L., Wedagedera, J. R., Small, B. G., Almond, L. M., Romero, K., Hermann, D., Hanna, D. L., Jamei, M., & Gardner, I. (2015) · CPT Pharmacometrics & Systems Pharmacology · doi:10.1002/psp4.12034 · Cited by 83 · see citing works

Development of a permeability-limited model of the human brain and cerebrospinal fluid (CSF) to integrate known physiological and biological knowledge: Estimating time varying CSF drug concentrations and their variability using in vitro data

Gaohua, L., Neuhoff, S., Johnson, T. N., Rostami‐Hodjegan, A., & Jamei, M. (2016) · Drug Metabolism and Pharmacokinetics · doi:10.1016/j.dmpk.2016.03.005 · Cited by 82 · see citing works

Physiologically Based Models in Regulatory Submissions: Output From the ABPI/MHRA Forum on Physiologically Based Modeling and Simulation

Shepard, T., Scott, G., Cole, S., Nordmark, A., & Bouzom, F. (2015) · CPT: Pharmacometrics & Systems Pharmacology · doi:10.1002/psp4.30 · Cited by 75 · see citing works

STUDIES ON THE DIFFUSION EFFECT UPON IONIC DISTRIBUTION

Teorell, T. (1937) · The Journal of General Physiology · doi:10.1085/jgp.21.1.107 · Cited by 75 · see citing works

Application of a Physiologically Based Pharmacokinetic Model to Predict OATP1B1‐Related Variability in Pharmacodynamics of Rosuvastatin

Rose, R., Neuhoff, S., Abduljalil, K., Chetty, M., Rostami‐Hodjegan, A., & Jamei, M. (2014) · CPT Pharmacometrics & Systems Pharmacology · doi:10.1038/psp.2014.24 · Cited by 75 · see citing works

A Generic Integrated Physiologically based Whole‐body Model of the Glucose‐Insulin‐Glucagon Regulatory System

Schaller, S., Willmann, S., Lippert, J., Schaupp, L., Pieber, T. R., Schuppert, A., & Eißing, T. (2013) · CPT Pharmacometrics & Systems Pharmacology · doi:10.1038/psp.2013.40 · Cited by 71 · see citing works

Physiologically Based Pharmacokinetic Model for Digoxin Disposition in Dogs and Its Preliminary Application to Humans

Harrison, L. I., & Gibaldi, M. (1977) · Journal of Pharmaceutical Sciences · doi:10.1002/jps.2600661206 · Cited by 67 · see citing works

Physiologically Based Pharmacokinetics Is Impacting Drug Development and Regulatory Decision Making

Rowland, M., Lesko, L., & Rostami‐Hodjegan, A. (2015) · CPT Pharmacometrics & Systems Pharmacology · doi:10.1002/psp4.52 · Cited by 63 · see citing works

Predicting drug–drug interactions: application of physiologically based pharmacokinetic models under a systems biology approach

Yeo, K., Jamei, M., & Rostami-Hodjegan, A. (2013) · Expert Review of Clinical Pharmacology · doi:10.1586/ecp.13.4 · Cited by 62 · see citing works

Applications of linking PBPK and PD models to predict the impact of genotypic variability, formulation differences, differences in target binding capacity and target site drug concentrations on drug responses and variability

Chetty, M., Rose, R. H., Abduljalil, K., Patel, N. K., Gaohua, L., Cain, T., Jamei, M., & Rostami‐Hodjegan, A. (2014) · Frontiers in Pharmacology · doi:10.3389/fphar.2014.00258 · Cited by 59 · see citing works

Preclinical Pharmacokinetic/Pharmacodynamic Modeling and Simulation in the Pharmaceutical Industry: An IQ Consortium Survey Examining the Current Landscape

Schuck, E. L., Bohnert, T., Chakravarty, A., Damian‐Iordache, V., Gibson, C. R., Hsu, C., Heimbach, T., Krishnatry, A. S., Liederer, B. M., Jing, L., et al. (2015) · The AAPS Journal · doi:10.1208/s12248-014-9716-2 · Cited by 52 · see citing works

Bayesian Population Physiologically-Based Pharmacokinetic (PBPK) Approach for a Physiologically Realistic Characterization of Interindividual Variability in Clinically Relevant Populations

Krauß, M., Tappe, K., Schuppert, A., Kuepfer, L., & Görlitz, L. (2015) · PLoS ONE · doi:10.1371/journal.pone.0139423 · Cited by 51 · see citing works

Physiologically Based Pharmacokinetic Modeling as a Tool to Predict Drug Interactions for Antibody-Drug Conjugates

Chen, Y., Samineni, D., Mukadam, S., Wong, H., Shen, B., Lu, D., Girish, S., Hop, C. E. C. A., Jin, J. Y., & Li, C. (2014) · Clinical Pharmacokinetics · doi:10.1007/s40262-014-0182-x · Cited by 50 · see citing works

Use of Physiologically Based Pharmacokinetic Models Coupled with Pharmacodynamic Models to Assess the Clinical Relevance of Current Bioequivalence Criteria for Generic Drug Products Containing Ibuprofen

Cristofoletti, R., & Dressman, J. (2014) · Journal of Pharmaceutical Sciences · doi:10.1002/jps.24076 · Cited by 47 · see citing works

Catalyzing the critical path initiative: FDA's progress in drug development activities

Parekh, A., Buckman‐Garner, S., McCune, S., O’Neill, R. T., Geanacopoulos, M., Amur, S., Clingman, C. S., Barratt, R., Rocca, M., Hills, I., et al. (2015) · Clinical Pharmacology & Therapeutics · doi:10.1002/cpt.42 · Cited by 37 · see citing works

Evaluating Systems Pharmacology Models Is Different From Evaluating Standard Pharmacokinetic–Pharmacodynamic Models

Agoram, B. (2014) · CPT: Pharmacometrics & Systems Pharmacology · doi:10.1038/psp.2013.77 · Cited by 30 · see citing works

Combining ‘Bottom-Up’ and ‘Top-Down’ Methods to Assess Ethnic Difference in Clearance: Bitopertin as an Example

Feng, S., Shi, J., Parrott, N. J., Hu, P., Weber, C., Martin‐Facklam, M., Saito, T., & Peck, R. (2015) · Clinical Pharmacokinetics · doi:10.1007/s40262-015-0356-1 · Cited by 28 · see citing works

The successes and failures of physiologically based pharmacokinetic modeling: there is room for improvement

Poggesi, I., Snoeys, J., & Peer, A. V. (2014) · Expert Opinion on Drug Metabolism & Toxicology · doi:10.1517/17425255.2014.888058 · Cited by 21 · see citing works

The application of global sensitivity analysis in the development of a physiologically based pharmacokinetic model for m-xylene and ethanol co-exposure in humans

Loizou, G. D., McNally, K., Jones, K., & Cocker, J. (2015) · Frontiers in Pharmacology · doi:10.3389/fphar.2015.00135 · Cited by 12 · see citing works

Prediction of Human Pharmacokinetics in 2013 and Beyond

Houston, J. B. (2013) · Drug Metabolism and Disposition · doi:10.1124/dmd.113.055376 · Cited by 10 · see citing works

QSAR without borders

Muratov, E. N., Bajorath, J., Sheridan, R. P., Tetko, I. V., Filimonov, D., Poroikov, V., Oprea, T. I., Baskin, I. I., Varnek, A., Roitberg, A., et al. (2020) · Chemical Society Reviews · doi:10.1039/d0cs00098a · Cited by 913 · see citing works

Why Has Model‐Informed Precision Dosing Not Yet Become Common Clinical Reality? Lessons From the Past and a Roadmap for the Future

Darwich, A. S., Ogungbenro, K., Vinks, A. A. T. M. M., Powell, J. R., Reny, J., Marsousi, N., Daali, Y., Fairman, D., Cook, J., Lesko, L. J., et al. (2017) · Clinical Pharmacology & Therapeutics · doi:10.1002/cpt.659 · Cited by 287 · see citing works

Cardiovascular disease models: A game changing paradigm in drug discovery and screening

Savoji, H., Mohammadi, M. H., Rafatian, N., Toroghi, M. K., Wang, E. Y., Zhao, Y., Korolj, A., Ahadian, S., & Radisic, M. (2019) · Biomaterials · doi:10.1016/j.biomaterials.2018.09.036 · Cited by 223 · see citing works

Physiologically-based pharmacokinetic models for children: Starting to reach maturation?

Verscheijden, L. F. M., Koenderink, J. B., Johnson, T. N., de Wildt, S. N., & Rüssel, F. G. M. (2020) · Pharmacology & Therapeutics · doi:10.1016/j.pharmthera.2020.107541 · Cited by 153 · see citing works

An in vitro toolbox to accelerate anti-malarial drug discovery and development

Charman, S. A., Andreu, A., Barker, H., Blundell, S. A., Campbell, A., Campbell, M., Chen, G., Chiu, F. C. K., Crighton, E., Katneni, K., et al. (2020) · Malaria Journal · doi:10.1186/s12936-019-3075-5 · Cited by 154 · 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

Applications, Challenges, and Outlook for PBPK Modeling and Simulation: A Regulatory, Industrial and Academic Perspective

Lin, W., Chen, Y., Unadkat, J. D., Zhang, X., Wu, D., & Heimbach, T. (2022) · Pharmaceutical Research · doi:10.1007/s11095-022-03274-2 · Cited by 137 · see citing works

Physiologically-based pharmacokinetic models: approaches for enabling personalized medicine

Hartmanshenn, C., Scherholz, M. L., & Androulakis, I. P. (2016) · Journal of Pharmacokinetics and Pharmacodynamics · doi:10.1007/s10928-016-9492-y · Cited by 136 · see citing works

Quantitative Proteomics of Clinically Relevant Drug-Metabolizing Enzymes and Drug Transporters and Their Intercorrelations in the Human Small Intestine

Couto, N. A. S., Al‐Majdoub, Z. M., Gibson, S., Davies, P. J., Achour, B., Harwood, M. D., Carlson, G., Barber, J., Rostami‐Hodjegan, A., & Warhurst, G. (2020) · Drug Metabolism and Disposition · doi:10.1124/dmd.119.089656 · Cited by 101 · 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

Quantification of Proteins Involved in Drug Metabolism and Disposition in the Human Liver Using Label-Free Global Proteomics

Couto, N. A. S., Al‐Majdoub, Z. M., Achour, B., Wright, P. C., Rostami‐Hodjegan, A., & Barber, J. (2019) · Molecular Pharmaceutics · doi:10.1021/acs.molpharmaceut.8b00941 · Cited by 94 · see citing works

Abundance of Phase 1 and 2 Drug-Metabolizing Enzymes in Alcoholic and Hepatitis C Cirrhotic Livers: A Quantitative Targeted Proteomics Study

Prasad, B., Bhatt, D. K., Johnson, K., Chapa, R., Chu, X., Salphati, L., Xiao, G., Lee, C. G. L., Hop, C. E. C. A., Mathias, A. A., et al. (2018) · Drug Metabolism and Disposition · doi:10.1124/dmd.118.080523 · Cited by 91 · see citing works

Bridging the Data Gap From in vitro Toxicity Testing to Chemical Safety Assessment Through Computational Modeling

Zhang, Q., Li, J., Middleton, A., Bhattacharya, S., & Conolly, R. B. (2018) · Frontiers in Public Health · doi:10.3389/fpubh.2018.00261 · Cited by 92 · see citing works

Pharmacokinetic–Pharmacodynamic Modeling in Pediatric Drug Development, and the Importance of Standardized Scaling of Clearance

Germovsek, E., Barker, C. I. S., Sharland, M., & Standing, J. F. (2018) · Clinical Pharmacokinetics · doi:10.1007/s40262-018-0659-0 · Cited by 81 · see citing works

Advancing internal exposure and physiologically-based toxicokinetic modeling for 21st-century risk assessments

Hubal, E. A. C., Wetmore, B. A., Wambaugh, J. F., El-Masri, H. A., Sobus, J. R., & Bahadori, T. (2018) · Journal of Exposure Science & Environmental Epidemiology · doi:10.1038/s41370-018-0046-9 · Cited by 80 · see citing works

Usefulness of PBPK Modeling in Incorporation of Clinical Conditions in Personalized Medicine

Marsousi, N., Desmeules, J. A., Rudaz, S. L., & Daali, Y. (2017) · Journal of Pharmaceutical Sciences · doi:10.1016/j.xphs.2017.04.035 · Cited by 76 · see citing works

Utilization of Physiologically Based Pharmacokinetic Modeling in Clinical Pharmacology and Therapeutics: an Overview

Perry, C., Davis, G., Conner, T. M., & Zhang, T. (2020) · Current Pharmacology Reports · doi:10.1007/s40495-020-00212-x · Cited by 75 · see citing works

Drug Dosing in Pregnant Women: Challenges and Opportunities in Using Physiologically Based Pharmacokinetic Modeling and Simulations

Ke, A. B., Greupink, R., & Abduljalil, K. (2018) · CPT Pharmacometrics & Systems Pharmacology · doi:10.1002/psp4.12274 · Cited by 74 · see citing works

A human population-based organotypic in vitro model for cardiotoxicity screening

Grimm, F. A. (2018) · ALTEX · doi:10.14573/altex.1805301 · Cited by 68 · see citing works

Prediction of olanzapine exposure in individual patients using physiologically based pharmacokinetic modelling and simulation

Polasek, T. M., Tucker, G. T., Sorich, M. J., Wiese, M. D., Mohan, T. S., Rostami‐Hodjegan, A., Korprasertthaworn, P., Perera, V., & Rowland, A. (2017) · British Journal of Clinical Pharmacology · doi:10.1111/bcp.13480 · Cited by 67 · see citing works

Current Approaches and Techniques in Physiologically Based Pharmacokinetic (PBPK) Modelling of Nanomaterials

Utembe, W., M.A., H. J. C. I., Sanabria, N. M., Doganis, P., & Gulumian, M. (2020) · Nanomaterials · doi:10.3390/nano10071267 · Cited by 69 · see citing works

Impact of Physiologically Based Pharmacokinetic Models on Regulatory Reviews and Product Labels: Frequent Utilization in the Field of Oncology

Yoshida, K. J., Budha, N. R., & Jin, J. (2017) · Clinical Pharmacology & Therapeutics · doi:10.1002/cpt.622 · Cited by 65 · see citing works

Clinical Drug–Drug Interaction Evaluations to Inform Drug Use and Enable Drug Access

Rekić, D., Reynolds, K. S., Zhao, P., Zhang, L., Yoshida, K. J., Sachar, M., Piquette‐Miller, M., Huang, S. M., & Zineh, I. (2017) · Journal of Pharmaceutical Sciences · doi:10.1016/j.xphs.2017.04.016 · Cited by 65 · see citing works

An integrated pathway based on in vitro data for the human hazard assessment of nanomaterials

Romeo, D., Salieri, B., Hischier, R., Nowack, B., & Wick, P. (2020) · Environment International · doi:10.1016/j.envint.2020.105505 · Cited by 62 · see citing works

PBPK model reporting template for chemical risk assessment applications

Tan, Y., Chan, M. P. L., Chukwudebe, A. C., Domoradzki, J. Y., Fisher, J. W., Hack, C. E., Hinderliter, P. M., Hirasawa, K., Leonard, J. A., Lumen, A., et al. (2020) · Regulatory Toxicology and Pharmacology · doi:10.1016/j.yrtph.2020.104691 · Cited by 62 · see citing works

New approach methodologies (NAMs) for human-relevant biokinetics predictions

Punt, A. (2020) · ALTEX · doi:10.14573/altex.2003242 · Cited by 61 · see citing works

Reviewing Data Integrated for PBPK Model Development to Predict Metabolic Drug-Drug Interactions: Shifting Perspectives and Emerging Trends

Abouir, K., Samer, C. F., Gloor, Y. S., Desmeules, J. A., & Daali, Y. (2021) · Frontiers in Pharmacology · doi:10.3389/fphar.2021.708299 · Cited by 59 · see citing works

Physiologically Based Pharmacokinetic Models Are Effective Support for Pediatric Drug Development

Wang, K., Jiang, K., Wei, X., Li, Y., Wang, T., & Song, Y. (2021) · AAPS PharmSciTech · doi:10.1208/s12249-021-02076-w · Cited by 57 · see citing works

Investigating the state of physiologically based kinetic modelling practices and challenges associated with gaining regulatory acceptance of model applications

Paini, A., Leonard, J. A., Kliment, T., Tan, Y., & Worth, A. P. (2017) · Regulatory Toxicology and Pharmacology · doi:10.1016/j.yrtph.2017.08.019 · Cited by 54 · see citing works

A Scoping Review of the Evidence Behind Cytochrome P450 2D6 Isoenzyme Inhibitor Classifications

Cicali, E. J., Smith, D. M., Duong, B. Q., Kovar, L., Cavallari, L. H., & Johnson, J. A. (2020) · Clinical Pharmacology & Therapeutics · doi:10.1002/cpt.1768 · Cited by 53 · see citing works

Prediction of pH-Dependent Drug-Drug Interactions for Basic Drugs Using Physiologically Based Biopharmaceutics Modeling: Industry Case Studies

Mitra, A., Parrott, N. J., Miller, N. A., Lloyd, R. S., Tistaert, C., Heimbach, T., Ji, Y., & Kesisoglou, F. (2019) · Journal of Pharmaceutical Sciences · doi:10.1016/j.xphs.2019.11.017 · Cited by 53 · see citing works

The Ontogeny of UDP-glucuronosyltransferase Enzymes, Recommendations for Future Profiling Studies and Application Through Physiologically Based Pharmacokinetic Modelling

Badée, J., Fowler, S., de Wildt, S. N., Collier, A., Schmidt, S., & Parrott, N. (2018) · Clinical Pharmacokinetics · doi:10.1007/s40262-018-0681-2 · Cited by 43 · see citing works

Global Proteomic Analysis of Human Liver Microsomes: Rapid Characterization and Quantification of Hepatic Drug-Metabolizing Enzymes

Achour, B., Feteisi, H. A., Lanucara, F., Rostami‐Hodjegan, A., & Barber, J. (2017) · Drug Metabolism and Disposition · doi:10.1124/dmd.116.074732 · Cited by 50 · see citing works

Towards best use and regulatory acceptance of generic physiologically based kinetic (PBK) models for in vitro-to-in vivo extrapolation (IVIVE) in chemical risk assessment

Najjar, A., Punt, A., Wambaugh, J. F., Paini, A., Ellison, C. A., Fragki, S., Bianchi, E., Zhang, F., Westerhout, J., Mueller, D., et al. (2022) · Archives of Toxicology · doi:10.1007/s00204-022-03356-5 · Cited by 50 · see citing works

Cannabinoids and drug metabolizing enzymes: potential for drug-drug interactions and implications for drug safety and efficacy

Bardhi, K., Coates, S., Watson, C. J. W., & Lazarus, P. J. (2022) · Expert Review of Clinical Pharmacology · doi:10.1080/17512433.2022.2148655 · Cited by 52 · see citing works

Antibody–Drug Conjugates as Cancer Therapeutics: Past, Present, and Future

Vezina, H. E., Cotreau, M. M., Han, T. H., & Gupta, M. (2017) · The Journal of Clinical Pharmacology · doi:10.1002/jcph.981 · Cited by 49 · see citing works

Physiologically Based Pharmacokinetic Models for Prediction of Complex CYP2C8 and OATP1B1 (SLCO1B1) Drug–Drug–Gene Interactions: A Modeling Network of Gemfibrozil, Repaglinide, Pioglitazone, Rifampicin, Clarithromycin and Itraconazole

Türk, D., Hanke, N., Wolf, S., Frechen, S., Eißing, T., Wendl, T., Schwab, M. G., & Lehr, T. (2019) · Clinical Pharmacokinetics · doi:10.1007/s40262-019-00777-x · Cited by 48 · see citing works

The Use of Physiologically Based Pharmacokinetic Analyses—in Biopharmaceutics Applications -Regulatory and Industry Perspectives

Anand, O., Pepin, X. J. H., Kolhatkar, V., & Seo, P. (2022) · Pharmaceutical Research · doi:10.1007/s11095-022-03280-4 · Cited by 47 · see citing works

Quantitative systems pharmacology and the personalized drug–microbiota–diet axis

Thiele, I., Clancy, C. M., Heinken, A., & Fleming, R. M. T. (2017) · Current Opinion in Systems Biology · doi:10.1016/j.coisb.2017.06.001 · Cited by 44 · see citing works

What Does it Take to Make Model-Informed Precision Dosing Common Practice? Report from the 1st Asian Symposium on Precision Dosing

Polasek, T. M., Rostami‐Hodjegan, A., Yim, D., Jamei, M., Lee, H., Kimko, H. H. C., Kim, J. K., Phương, N. T. T., Darwich, A. S., & Shin, J. (2019) · The AAPS Journal · doi:10.1208/s12248-018-0286-6 · Cited by 46 · see citing works

Development of a physiologically-based pharmacokinetic pediatric brain model for prediction of cerebrospinal fluid drug concentrations and the influence of meningitis

Verscheijden, L. F. M., Koenderink, J. B., de Wildt, S. N., & Rüssel, F. G. M. (2019) · PLoS Computational Biology · doi:10.1371/journal.pcbi.1007117 · Cited by 45 · see citing works

Progress in Prediction and Interpretation of Clinically Relevant Metabolic Drug-Drug Interactions: a Minireview Illustrating Recent Developments and Current Opportunities

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

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Willmann, S., Coboeken, K., Kapsa, S., Thelen, K., Mundhenke, M., Fischer, K., Hügl, B. J., & Mück, W. M. (2020) · The Journal of Clinical Pharmacology · doi:10.1002/jcph.1784 · Cited by 36 · see citing works

Phenotypic chemical biology for predicting safety and efficacy

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Physiologically Based Pharmacokinetic Model Predictions of Panobinostat (LBH589) as a Victim and Perpetrator of Drug-Drug Interactions

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Einolf, H. J., Zhou, J., Won, C. S., Wang, L., & Rebello, S. S. (2017) · Drug Metabolism and Disposition · doi:10.1124/dmd.116.073585 · Cited by 32 · see citing works

Sound understanding of environmental, health and safety, clinical, and market aspects is imperative to clinical translation of nanomedicines

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Physiologically Based Pharmacokinetic/Pharmacodynamic Modeling to Support Waivers of In Vivo Clinical Studies: Current Status, Challenges, and Opportunities

Loisios-Konstantinidis, I., & Dressman, J. (2020) · Molecular Pharmaceutics · doi:10.1021/acs.molpharmaceut.0c00903 · Cited by 30 · see citing works

IntegratingIn Vitro, Modeling, andIn VivoApproaches to Investigate Warfarin Bioequivalence

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Investigating Oral Absorption of Carbamazepine in Pediatric Populations

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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

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Ontogeny of Drug-Metabolizing Enzymes

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Population PBPK modeling using parametric and nonparametric methods of the Simcyp Simulator, and Bayesian samplers

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Analysis of Clinical Drug-Drug Interaction Data To Predict Magnitudes of Uncharacterized Interactions between Antiretroviral Drugs and Comedications

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Physiologically‐based pharmacokinetics of ziprasidone in pregnant women

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Nursing Personnel in the Era of Personalized Healthcare in Clinical Practice

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Kesisoglou, F. (2020) · The Journal of Clinical Pharmacology · doi:10.1002/jcph.1678 · Cited by 22 · see citing works

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Mittal, V. K., & Ng, C. A. (2018) · Chemosphere · doi:10.1016/j.chemosphere.2018.03.064 · Cited by 22 · see citing works

The development of a population physiologically based pharmacokinetic model for mycophenolic mofetil and mycophenolic acid in humans using data from plasma, saliva, and kidney tissue

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Development of a paediatric physiologically based pharmacokinetic model to assess the impact of drug-drug interactions in tuberculosis co-infected malaria subjects: A case study with artemether-lumefantrine and the CYP3A4-inducer rifampicin

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Computational Fluid-Particle Dynamics Modeling for Unconventional Inhaled Aerosols in Human Respiratory Systems

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Does the choice of applied physiologically‐based pharmacokinetics platform matter? A case study on simvastatin disposition and drug–drug interaction

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Multi-scale models of whole cells: progress and challenges

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PBPK application: From academic research to routine use in drug development and regulation

Zhao, P. (2018) · Proceedings for Annual Meeting of The Japanese Pharmacological Society · doi:10.1254/jpssuppl.wcp2018.0_sy53-1

Regulatory Requirements and Applications of Physiologically Based Pharmacokinetic Models

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Impact of Physiologically Based Pharmacokinetic Models on Regulatory Reviews and Product Labels: Frequent Utilization in the Field of Oncology

Yoshida, K. J., Budha, N. R., & Jin, J. (2017) · Clinical Pharmacology & Therapeutics · doi:10.1002/cpt.622 · Cited by 65 · see citing works

Applications of Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulation During Regulatory Review

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Physiologically based pharmacokinetic modeling in drug discovery and development: A pharmaceutical industry perspective

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