User profiles for Kenichi Umehara
 | Kenichi UmeharaRoche Pharmaceutical Research and Early Development Verified email at roche.com Cited by 762 |
Ribociclib Bioavailability Is Not Affected by Gastric pH Changes or Food Intake: In Silico and Clinical Evaluations
…, M Mueller‐Zsigmondy, K Umehara… - Clinical …, 2018 - Wiley Online Library
Ribociclib (KISQALI), a cyclin‐dependent kinase 4/6 inhibitor approved for the first‐line
treatment of HR+/HER2– advanced breast cancer with an aromatase inhibitor, is administered …
treatment of HR+/HER2– advanced breast cancer with an aromatase inhibitor, is administered …
Therapeutic protein drug interactions: a white paper from the international consortium for innovation and quality in pharmaceutical development
…, H Schiller, G Tai, K Umehara… - Clinical …, 2023 - Wiley Online Library
Typically, therapeutic proteins (TPs) have a low risk for eliciting meaningful drug interactions
(DIs). However, there are select instances where TP drug interactions (TP‐DIs) of clinical …
(DIs). However, there are select instances where TP drug interactions (TP‐DIs) of clinical …
Current practices, gap analysis, and proposed workflows for PBPK modeling of cytochrome P450 induction: an industry perspective
…, H Chanteux, J Mao, K Umehara… - Clinical …, 2022 - Wiley Online Library
The International Consortium for Innovation and Quality (IQ) Physiologically Based
Pharmacokinetic (PBPK) Modeling Induction Working Group (IWG) conducted a survey across …
Pharmacokinetic (PBPK) Modeling Induction Working Group (IWG) conducted a survey across …
In Vitro to In Vivo Extrapolation of Metabolic Clearance for UGT Substrates Using Short-Term Suspension and Long-Term Co-cultured Human Hepatocytes
L Docci, F Klammers, A Ekiciler, B Molitor, K Umehara… - The AAPS journal, 2020 - Springer
The use of micro-patterned co-cultured hepatocytes for human hepatic clearance predictions
has previously been demonstrated using drugs metabolized by cytochrome P450 enzymes. …
has previously been demonstrated using drugs metabolized by cytochrome P450 enzymes. …
Prediction of the Impact of Cytochrome P450 2C9 Genotypes on the Drug–Drug Interaction Potential of Siponimod With Physiologically‐Based Pharmacokinetic …
F Huth, A Gardin, K Umehara… - Clinical Pharmacology & …, 2019 - Wiley Online Library
We predicted the drug–drug interaction ( DDI ) potential of siponimod in presence of
cytochrome P450 ( CYP )2C9/ CYP 3A4 inhibitors/inducers in subjects with different CYP 2C9 …
cytochrome P450 ( CYP )2C9/ CYP 3A4 inhibitors/inducers in subjects with different CYP 2C9 …
Drug-drug interaction (DDI) assessments of ruxolitinib, a dual substrate of CYP3A4 and CYP2C9, using a verified physiologically based pharmacokinetic (PBPK) …
K Umehara, F Huth, Y Jin, H Schiller… - Drug metabolism and …, 2019 - degruyter.com
Ruxolitinib is mainly metabolized by cytochrome P450 (CYP) enzymes CYP3A4 and CYP2C9
followed by minor contributions of other hepatic CYP enzymes in vitro. A physiologically …
followed by minor contributions of other hepatic CYP enzymes in vitro. A physiologically …
Construction and verification of physiologically based pharmacokinetic models for four drugs majorly cleared by glucuronidation: Lorazepam, oxazepam, naloxone …
L Docci, K Umehara, S Krähenbühl, S Fowler… - The AAPS journal, 2020 - Springer
Physiologically based pharmacokinetic (PBPK) modeling is less well established for substrates
of UDP-glucuronosyltransferases (UGT) than for cytochrome P450 (CYP) metabolized …
of UDP-glucuronosyltransferases (UGT) than for cytochrome P450 (CYP) metabolized …
Ribociclib drug‐drug interactions: Clinical evaluations and physiologically‐based pharmacokinetic modeling to guide drug labeling
Ribociclib is approved in combination with endocrine therapy as initial endocrine‐based
therapy for HR‐positive and HER2‐negative advanced breast cancer. Ribociclib is primarily …
therapy for HR‐positive and HER2‐negative advanced breast cancer. Ribociclib is primarily …
Dose adjustment in patients with liver cirrhosis–comparison of two different modeling approaches
…, P Annaert, S Fowler, K Umehara… - Clinical …, 2023 - Wiley Online Library
Failure to perform adequate dose adjustment in patients with liver cirrhosis may be associated
with increased toxicity. We compared the prediction of area under the curve (AUC) and …
with increased toxicity. We compared the prediction of area under the curve (AUC) and …
[HTML][HTML] The Activity of Members of the UDP-Glucuronosyltransferase Subfamilies UGT1A and UGT2B is Impaired in Patients with Liver Cirrhosis
U Duthaler, F Bachmann, AC Ozbey, K Umehara… - Clinical …, 2023 - Springer
Background and Objective The impact of liver cirrhosis on the activity of UDP-glucuronosyltransferases
(UGTs) is currently not well characterized. We investigated the glucuronidation …
(UGTs) is currently not well characterized. We investigated the glucuronidation …