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British Journal of Clinical Pharmacology|June 2, 2023
Evaluation of the drug disposition of RO7049389 with in vitro data and human mass balance supported by physiologically based pharmacokinetic modellingYuchen Zhang, Kenichi Umehara, Andrea A Romeo, et al.Clinical Pharmacology and Therapeutics|June 20, 2020
Ribociclib Drug-Drug Interactions: Clinical Evaluations and Physiologically-Based Pharmacokinetic Modeling to Guide Drug LabelingTanay S Samant, Felix Huth, Kenichi Umehara, et al.Clinical Pharmacology and Therapeutics|November 15, 2017
Ribociclib Bioavailability Is Not Affected by Gastric pH Changes or Food Intake: In Silico and Clinical EvaluationsTanay S Samant, Shyeilla Dhuria, Yasong Lu, et al.Drug Metabolism and Disposition: the Biological Fate of Chemicals|April 9, 2025
Prediction of hepatic metabolic clearance in rats and dogs using long-term cocultured hepatocytesKenichi Umehara, Florian Klammers, Isabelle Walter, et al.Drug Metabolism and Disposition: the Biological Fate of Chemicals|October 8, 2021
Addressing Today's Absorption, Distribution, Metabolism, and Excretion (ADME) Challenges in the Translation of In Vitro ADME Characteristics to Humans: A Case Study of the SMN2 mRNA Splicing Modifier RisdiplamStephen Fowler, Andreas Brink, Yumi Cleary, et al.Investigational New Drugs|August 21, 2021
In vitro and clinical investigations to determine the drug-drug interaction potential of entrectinib, a small molecule inhibitor of neurotrophic tyrosine receptor kinase (NTRK)Georgina Meneses-Lorente, Stephen Fowler, Elena Guerini, et al.Clinical Pharmacology and Therapeutics|December 8, 2022
Therapeutic Protein Drug Interactions: A White Paper From the International Consortium for Innovation and Quality in Pharmaceutical DevelopmentDavid E Coutant, David W Boulton, Upendra P Dahal, et al.Drug Metabolism and Pharmacokinetics|January 6, 2026
Future directions in drug-drug interaction evaluations: Industry perspective on the ICH M12 guidanceKenichi Umehara, Andrew Harrell, Chandra Prakash, et al.Drug Metabolism and Disposition: the Biological Fate of Chemicals|June 11, 2026
In vitro reversible enzyme inhibition assays to predict drug-drug interactions: Current state and industry perspective from the IQ Consortium Enzyme Inhibition Working GroupCarlo Sensenhauser, Sarah M Glass, Upendra P Dahal, et al.Journal of Pharmacokinetics and Pharmacodynamics|August 11, 2022
Current practices for QSP model assessment: an IQ consortium surveyJason R Chan, Richard Allen, Britton Boras, et al.Pageof 5