A cross-species assessment of in silico prediction methods of steady-state volume of distribution using Simcyp simulators

Authors: Ning, Miaoran ^a, Fang, Ma ^a, Shah, Kushal ^{b, c}, Dixit, Vaishali ^d, Pade, Devendra ^{e, f}, Musther, Helen ^e, Neuhoff, Sibylle ^{e, ⁎}

Source: In Journal of Pharmaceutical Sciences February 2025 114(2):1410-1422

Considerations for Physiologically Based Modeling in Liver Disease: From Nonalcoholic Fatty Liver (NAFL) to Nonalcoholic Steatohepatitis (NASH)

Authors: Murphy, William A., Adiwidjaja, Jeffry, Sjöstedt, Noora, Yang, Kyunghee, Beaudoin, James J., Spires, Jessica, Siler, Scott Q., Neuhoff, Sibylle, Brouwer, Kim L.R.

Source: Clinical pharmacology & therapeutics. 113(2):275-297

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Non-specific binding of compounds in in vitro metabolism assays: a comparison of microsomal and hepatocyte binding in different species and an assessment of the accuracy of prediction models

Authors: Gardner, Iain, Xu, Mandy, Han, Chunyan, Wang, Yi, Jiao, Xingjin, Jamei, Masoud, Khalidi, Hiba, Kilford, Peter, Neuhoff, Sibylle, Southall, Roz, Turner, David B., Musther, Helen, Jones, Barry, Taylor, Simon

Source: Xenobiotica. 52(8):943-956

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Clinical Relevance of Hepatic and Renal P‐gp/BCRP Inhibition of Drugs: An International Transporter Consortium Perspective

Authors: Taskar, Kunal S., Yang, Xinning, Neuhoff, Sibylle, Patel, Mitesh, Yoshida, Kenta, Paine, Mary F., Brouwer, Kim L.R., Chu, Xiaoyan, Sugiyama, Yuichi, Cook, Jack, Polli, Joseph W., Hanna, Imad, Lai, Yurong, Zamek‐Gliszczynski, Maciej

Source: Clinical pharmacology & therapeutics. 112(3):573-592

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Clinical Implications of Altered Drug Transporter Abundance/Function and PBPK Modeling in Specific Populations: An ITC Perspective

Authors: Chu, Xiaoyan, Prasad, Bhagwat, Neuhoff, Sibylle, Yoshida, Kenta, Leeder, James Steven, Mukherjee, Dwaipayan, Taskar, Kunal, Varma, Manthena V. S., Zhang, Xinyuan, Yang, Xinning, Galetin, Aleksandra

Source: Clinical pharmacology & therapeutics. 112(3):501-526

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Regulation of Drug Transport Proteins—From Mechanisms to Clinical Impact: A White Paper on Behalf of the International Transporter Consortium

Authors: Brouwer, Kim L.R., Evers, Raymond, Hayden, Elizabeth, Hu, Shuiying, Li, Cindy Yanfei, Meyer zu Schwabedissen, Henriette E., Neuhoff, Sibylle, Oswald, Stefan, Piquette‐Miller, Micheline, Saran, Chitra, Sjöstedt, Noora, Sprowl, Jason A., Stahl, Simone H., Yue, Wei

Source: Clinical pharmacology & therapeutics. 112(3):461-484

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Prediction of CYP‐mediated DDIs involving inhibition: Approaches to address the requirements for system qualification of the Simcyp Simulator

Authors: Kilford, Peter J., Chen, Kuan‐Fu, Crewe, Kim, Gardner, Iain, Hatley, Oliver, Ke, Alice Ban, Neuhoff, Sibylle, Zhang, Mian, Rowland Yeo, Karen

Source: CPT: pharmacometrics & systems pharmacology. 11(7):822-832

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Guide to development of compound files for PBPK modeling in the Simcyp population‐based simulator

Authors: Ezuruike, Udoamaka, Zhang, Mian, Pansari, Amita, De Sousa Mendes, Mailys, Pan, Xian, Neuhoff, Sibylle, Gardner, Iain

Source: CPT: pharmacometrics & systems pharmacology. 11(7):805-821

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Application of proteomic data in the translation of in vitro observations to associated clinical outcomes

Authors: Neuhoff, Sibylle, Harwood, Matthew D., Rostami-Hodjegan, Amin, Achour, Brahim

Source: In Drug Discovery Today: Technologies December 2021 39:13-22

Assessing OATP1B1- and OATP1B3-Mediated Drug-Drug Interaction Potential of Vemurafenib Using R-Value and Physiologically-Based Pharmacokinetic Models

Authors: Kayesh, Ruhul, Farasyn, Taleah, Crowe, Alexandra, Liu, Qiang, Pahwa, Sonia, Alam, Khondoker, Neuhoff, Sibylle, Hatley, Oliver, Ding, Kai, Yue, Wei

Source: In Journal of Pharmaceutical Sciences January 2021 110(1):314-324

Unraveling pleiotropic effects of rifampicin by using physiologically based pharmacokinetic modeling: Assessing the induction magnitude of P‐glycoprotein–cytochrome P450 3A4 dual substrates

Authors: Pan, Xian, Yamazaki, Shinji, Neuhoff, Sibylle, Zhang, Mian, Pilla Reddy, Venkatesh

Source: CPT: pharmacometrics & systems pharmacology. 10(12):1485-1496

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Food constituent– and herb–drug interactions in oncology: Influence of quantitative modelling on Drug labelling

Authors: Pilla Reddy, Venkatesh, Jo, Heeseung, Neuhoff, Sibylle

Source: British journal of clinical pharmacology. 87(10):3988-4000

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Physiologically‐Based Pharmacokinetic Model of Morphine and Morphine‐3‐Glucuronide in Nonalcoholic Steatohepatitis

Authors: Sjöstedt, Noora, Neuhoff, Sibylle, Brouwer, Kim L.R.

Source: Clinical pharmacology & therapeutics. 109(3):676-687

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Intestinal P‐gp and Putative Hepatic OATP1B Induction: International Transporter Consortium Perspective on Drug Development Implications

Authors: Zamek‐Gliszczynski, Maciej J., Patel, Mitesh, Yang, Xinning, Lutz, Justin D., Chu, Xiaoyan, Brouwer, Kim L. R., Lai, Yurong, Lee, Caroline A., Neuhoff, Sibylle, Paine, Mary F., Sugiyama, Yuichi, Taskar, Kunal S., Galetin, Aleksandra

Source: Clinical pharmacology & therapeutics. 109(1):55-64

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Applications of the Cholesterol Metabolite, 4β-Hydroxycholesterol, as a Sensitive Endogenous Biomarker for Hepatic CYP3A Activity Evaluated within a PBPK Framework.

Authors: Karkhanis, Aneesh V., Harwood, Matthew D., Stader, Felix, Bois, Frederic Y., Neuhoff, Sibylle

Source: Pharmaceutics; Oct2024, Vol. 16 Issue 10, p1284, 22p

Subject Terms: CYTOCHROME P-450 CYP3A, PLASMA confinement, BIOMARKERS, CHOLESTEROL, PHARMACOKINETICS

A Laboratory-Specific Scaling Factor to Predict the In Vivo Human Clearance of Aldehyde Oxidase Substrates

Authors: De Sousa Mendes, Mailys ¹, L. Orton, Alexandra, Humphries, Helen E., Jones, Barry, Gardner, Iain, Neuhoff, Sibylle, Pilla Reddy, Venkatesh ^*

Source: In Drug Metabolism and Disposition November 2020 48(11):1231-1238

Preincubation With Everolimus and Sirolimus Reduces Organic Anion-Transporting Polypeptide (OATP)1B1- and 1B3-Mediated Transport Independently of mTOR Kinase Inhibition: Implication in Assessing OATP1B1- and OATP1B3-Mediated Drug-Drug Interactions

Authors: Farasyn, Taleah, Crowe, Alexandra, Hatley, Oliver, Neuhoff, Sibylle, Alam, Khondoker, Kanyo, Jean, Lam, TuKiet T., Ding, Kai, Yue, Wei

Source: In Journal of Pharmaceutical Sciences October 2019 108(10):3443-3456

The Regional-Specific Relative and Absolute Expression of Gut Transporters in Adult Caucasians: A Meta-Analysis

Authors: Harwood, Matthew D. ^*, Zhang, Mian, Pathak, Shriram M. ¹, Neuhoff, Sibylle

Source: In Drug Metabolism and Disposition August 2019 47(8):854-864

Mass spectrometry‐based abundance atlas of ABC transporters in human liver, gut, kidney, brain and skin

Authors: Al‐Majdoub, Zubida M., Achour, Brahim, Couto, Narciso, Howard, Martyn, Elmorsi, Yasmine, Scotcher, Daniel, Alrubia, Sarah, El‐Khateeb, Eman, Vasilogianni, Areti‐Maria, Alohali, Noura, Neuhoff, Sibylle, Schmitt, Lutz, Rostami‐Hodjegan, Amin, Barber, Jill

Source: FEBS letters. 594(23):4134-4150

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Physiologically‐Based Pharmacokinetic Models for Evaluating Membrane Transporter Mediated Drug–Drug Interactions: Current Capabilities, Case Studies, Future Opportunities, and Recommendations

Authors: Taskar, Kunal S., Pilla Reddy, Venkatesh, Burt, Howard, Posada, Maria M., Varma, Manthena, Zheng, Ming, Ullah, Mohammed, Emami Riedmaier, Arian, Umehara, Ken‐ichi, Snoeys, Jan, Nakakariya, Masanori, Chu, Xiaoyan, Beneton, Maud, Chen, Yuan, Huth, Felix, Narayanan, Rangaraj, Mukherjee, Dwaipayan, Dixit, Vaishali, Sugiyama, Yuichi, Neuhoff, Sibylle

Source: Clinical pharmacology & therapeutics. 107(5):1082-1115

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100107696575.0x000001&indx=1&recIds=ETOCvdc_100107696575.0x000001