The extended clearance model and its use for the interpretation of hepatobiliary elimination data

Drug Metabolism and Drug Interactions

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Pharmacogenetics in Latin American populations: regulatory aspects, application to herbal medicine, cardiovascular and psychiatric disorders

Rodeiro, I., Figueredo, D. R., Mesa, M. G., Dorado, P., & LLerena, A. (2012) · Drug metabolism and drug interactions · doi:10.1515/dmdi-2012-0006 · Cited by 30 · see citing works

BDDCS, the Rule of 5 and drugability

Benet, L. Z., Hosey, C. M., Ursu, O., & Oprea, T. I. (2016) · Advanced Drug Delivery Reviews · doi:10.1016/j.addr.2016.05.007 · Cited by 912 · see citing works

Predicting Clearance Mechanism in Drug Discovery: Extended Clearance Classification System (ECCS)

Varma, M. V., Steyn, S. J., Allerton, C., & El-Kattan, A. F. (2015) · Pharmaceutical Research · doi:10.1007/s11095-015-1749-4 · Cited by 334 · see citing works

Clearance in Drug Design

Smith, D. A., Beaumont, K. C., Maurer, T. S., & Di, L. (2018) · Journal of Medicinal Chemistry · doi:10.1021/acs.jmedchem.8b01263 · Cited by 193 · see citing works

Interpretation of Non-Clinical Data for Prediction of Human Pharmacokinetic Parameters: In Vitro-In Vivo Extrapolation and Allometric Scaling

Choi, G.-W., Lee, Y.-B., & Cho, H.-Y. (2019) · Pharmaceutics · doi:10.3390/pharmaceutics11040168 · Cited by 76 · see citing works

In Silico ADME Profiling of Salubrinal and Its Analogues

Zadorozhnii, P. V., Kiselev, V. V., & Kharchenko, A. V. (2022) · Future Pharmacology · doi:10.3390/futurepharmacol2020013 · Cited by 58 · see citing works

Primary Human Hepatocyte Spheroids as an In Vitro Tool for Investigating Drug Compounds with Low Hepatic Clearance

Riede, J., Wollmann, B. M., Molden, E., & Ingelman‐Sundberg, M. (2021) · Drug Metabolism and Disposition · doi:10.1124/dmd.120.000340 · Cited by 53 · see citing works

Drug Disposition Classification Systems in Discovery and Development: A Comparative Review of the BDDCS, ECCS and ECCCS Concepts

Camenisch, G. (2016) · Pharmaceutical Research · doi:10.1007/s11095-016-2001-6 · Cited by 41 · see citing works

Current In Vitro Methods to Determine Hepatic Kp uu : A Comparison of Their Usefulness and Limitations

Riede, J., Camenisch, G., Huwyler, J., & Poller, B. (2017) · Journal of Pharmaceutical Sciences · doi:10.1016/j.xphs.2017.03.025 · Cited by 33 · see citing works

Drug-drug interaction (DDI) assessments of ruxolitinib, a dual substrate of CYP3A4 and CYP2C9, using a verified physiologically based pharmacokinetic (PBPK) model to support regulatory submissions

Umehara, K., Huth, F., Jin, Y., Schiller, H., Aslanis, V., Heimbach, T., & He, H. (2019) · Drug Metabolism and Personalized Therapy · doi:10.1515/dmpt-2018-0042 · Cited by 32 · see citing works

Membrane transporter data to support kinetically-informed chemical risk assessment using non-animal methods: Scientific and regulatory perspectives

Clerbaux, L., Paini, A., Lumen, A., Osman‐Ponchet, H., Worth, A. P., & Fardel, O. (2019) · Environment International · doi:10.1016/j.envint.2019.03.003 · Cited by 33 · see citing works

Current Approaches for Predicting Human PK for Small Molecule Development Candidates: Findings from the IQ Human PK Prediction Working Group Survey

Petersson, C., Zhou, X., Berghausen, J., Cebrián, D. Á., Davies, M., DeMent, K., Eddershaw, P. J., Riedmaier, A. E., Leblanc, A. F., Manveski, N., et al. (2022) · The AAPS Journal · doi:10.1208/s12248-022-00735-9 · Cited by 28 · see citing works

New IVIVE method for the prediction of total human clearance and relative elimination pathway contributions from in vitro hepatocyte and microsome data

Riede, J., Poller, B., Umehara, K.-I., Huwyler, J., & Camenisch, G. (2016) · European Journal of Pharmaceutical Sciences · doi:10.1016/j.ejps.2016.02.022 · Cited by 21 · see citing works

Use of imaging to assess the activity of hepatic transporters

Hernández-Lozano, I., & Langer, O. (2020) · Expert Opinion on Drug Metabolism & Toxicology · doi:10.1080/17425255.2020.1718107 · Cited by 21 · see citing works

Assessing the Risk of Drug-Induced Cholestasis Using Unbound Intrahepatic Concentrations

Riede, J., Poller, B., Huwyler, J., & Camenisch, G. (2017) · Drug Metabolism and Disposition · doi:10.1124/dmd.116.074179 · Cited by 19 · see citing works

Examining P-gp efflux kinetics guided by the BDDCS – Rational selection of in vitro assay designs and mathematical models

Riede, J., Umehara, K., Schweigler, P., Huth, F., Schiller, H., Camenisch, G., & Poller, B. (2019) · European Journal of Pharmaceutical Sciences · doi:10.1016/j.ejps.2019.03.005 · Cited by 14 · see citing works

No effects of pantoprazole on the pharmacokinetics of rosuvastatin in healthy subjects

Huguet, J., Lu, J., Gaudette, F., Chiasson, J. L., Hamet, P., Michaud, V., & Turgeon, J. (2016) · European Journal of Clinical Pharmacology · doi:10.1007/s00228-016-2065-6 · Cited by 14 · see citing works

Predicting transporter mediated drug–drug interactions via static and dynamic physiologically based pharmacokinetic modeling: A comprehensive insight on where we are now and the way forward

Vijaywargi, G., Kollipara, S., Ahmed, T., & Chachad, S. (2022) · Biopharmaceutics & Drug Disposition · doi:10.1002/bdd.2339 · Cited by 13 · see citing works

Theoretical Considerations for Direct Translation of Unbound Liver-to-Plasma Partition Coefficient from In Vitro to In Vivo

Li, Z., Di, L., & Maurer, T. S. (2019) · The AAPS Journal · doi:10.1208/s12248-019-0314-1 · Cited by 13 · see citing works

Challenging the Relevance of Unbound Tissue-to-Blood Partition Coefficient (Kpuu) on Prediction of Drug-Drug Interactions

Sodhi, J. K., Liu, S., & Benet, L. Z. (2020) · Pharmaceutical Research · doi:10.1007/s11095-020-02797-w · Cited by 10 · see citing works

Overcoming the shortcomings of the extended-clearance concept: a framework for developing a physiologically-based pharmacokinetic (PBPK) model to select drug candidates involving transporter-mediated clearance

Liang, X., & Lai, Y. (2021) · Expert Opinion on Drug Metabolism & Toxicology · doi:10.1080/17425255.2021.1912012 · Cited by 10 · see citing works

Prediction of Drug Clearance from Enzyme and Transporter Kinetics

Kulkarni, P., Youssef, A. S., & Argikar, A. A. (2021) · Methods in molecular biology · doi:10.1007/978-1-0716-1554-6_14 · Cited by 7 · see citing works

Drug-Induced Liver Injury Predictions: Extended Clearance Model and Its Use for Prospective Transporter and Enzyme-Based Hepatic Cell Stress Grading

Camenisch, G. (2019) · International Journal of Pharmacy and Chemistry · doi:10.11648/j.ijpc.20190502.11 · Cited by 3 · see citing works

In Vitro/In Vivo Correlation for Transporters

Cvijić, S. (2018) · Springer eBooks · doi:10.1007/978-3-319-56637-5_22-1 · Cited by 3 · see citing works

How predictive are isolated perfused liver data of in vivo hepatic clearance? A meta-analysis of isolated perfused rat liver data

Schulz, J., & Kalvass, J. C. (2024) · Xenobiotica · doi:10.1080/00498254.2024.2404170 · Cited by 2 · see citing works

Clearance prediction with three novel plated human hepatocyte models compared to conventional suspension assays: Assessment with 50 compounds and multiple donors

Kukla, D. A., Schulz, J., Lesniak, P. R., Sande, E., Wang, Y.-T., Kalvass, J. C., & Stresser, D. M. (2024) · Drug Metabolism and Disposition · doi:10.1016/j.dmd.2024.100032 · Cited by 2 · see citing works

A commentary on “Are all measures of liver Kpuu a function of F, as determined following oral dosing, or have we made a critical error in defining hepatic drug clearance?”

Sugano, K. (2024) · European Journal of Pharmaceutical Sciences · doi:10.1016/j.ejps.2024.106799 · Cited by 2 · see citing works

The Extended Clearance Model

Poller, B., Huth, F., Kastrinou‐Lampou, V., Kullak-Ublick, G. A., Arand, M., & Camenisch, G. (2021) · Wiley eBooks · doi:10.1002/9781119171003.ch15 · Cited by 2 · see citing works

Uridine 5′-Diphospho-glucuronosyltransferase 1A3 (UGT1A3) Prediction of Hepatic Clearance of Organic Anion Transporting Polypeptide 1B3 (OATP1B3) Substrate Telmisartan by Glucuronidation Using In Vitro–In Vivo Extrapolation (IVIVE)

Gabor-Worwa, E., Kowal-Chwast, A., Gaud, N., Gogola, D., Littlewood, P., Smoluch, M. T., Brzózka, K. D., & Kuś, K. (2024) · European Journal of Drug Metabolism and Pharmacokinetics · doi:10.1007/s13318-024-00895-3 · Cited by 1 · see citing works

Integrated Lead Optimization: Translational Models as We Advance Toward the Clinic

Liederer, B. M., Liu, X., Wong, S. G. W., & Mudra, D. R. (2017) · AAPS advances in the pharmaceutical sciences series · doi:10.1007/978-3-319-50042-3_6

In/In Vivo Correlation for Transporters

Cvijić, S. (2020) · Springer eBooks · doi:10.1007/978-3-319-68864-0_22

Strategies to Improve Pharmacokinetics of Hepatic Uptake Transporter Substrates

Glass, S. M., Polidori, D., Coe, K. J., Venkatesan, H., & Burns, A. S. (2025) · Journal of Medicinal Chemistry · doi:10.1021/acs.jmedchem.5c00437

Deconvoluting the in vitro to in vivo drug clearance gap: Questioning the predictive performance of traditional hepatic clearance models

Heylen, S., Nicolaï, J., Asten, S. V., Wagter, K. D., Treyer, A., Snoeys, J., Evers, R., Kourula, S., & Annaert, P. (2026) · European Journal of Pharmaceutical Sciences · doi:10.1016/j.ejps.2026.107427

Membrane Transport in Hepatic Clearance of Drugs I: Extended Hepatic Clearance Models Incorporating Concentration-Dependent Transport and Elimination Processes

Kwon, Y., & Morris, M. E. (1997) · Pharmaceutical Research · doi:10.1023/a:1012106623696 · Cited by 15 · see citing works

Hepatic Clearance Measurements and Pharmacokinetics

Keiding, S., & Buch Andreasen, P. (2008) · Pharmacology · doi:10.1159/000137296 · Cited by 23 · see citing works

Extended Clearance Concept and physiologically-based pharmacokinetic (PBPK) modeling for predicting transporter/enzyme-mediated complex drug-drug interactions based on in vitro measured parameters

Sugiyama, Y. (2018) · Proceedings for Annual Meeting of The Japanese Pharmacological Society · doi:10.1254/jpssuppl.wcp2018.0_sy31-1

Predicting human hepatic clearance from<i>in vitro</i>drug metabolism and transport data: a scientific and pharmaceutical perspective for assessing drug–drug interactions

Camenisch, G., & Umehara, K. (2012) · Biopharmaceutics &amp; Drug Disposition · doi:10.1002/bdd.1784 · Cited by 76 · see citing works

In vitro-in vivo extrapolation of hepatic clearance involving active uptake: Theoretical and experimental aspects

Webborn, P. J. H., Parker, A. J., Denton, R., & Riley, R. J. (2007) · Xenobiotica · doi:10.3109/00498250701557266 · Cited by 64 · see citing works