Y
Yumi Cleary
Researcher at Hoffmann-La Roche
Publications - 16
Citations - 477
Yumi Cleary is an academic researcher from Hoffmann-La Roche. The author has contributed to research in topics: Physiologically based pharmacokinetic modelling & Alectinib. The author has an hindex of 9, co-authored 15 publications receiving 328 citations. Previous affiliations of Yumi Cleary include University of Manchester.
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Journal ArticleDOI
Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective.
Mohamad Shebley,Punam Sandhu,Arian Emami Riedmaier,Masoud Jamei,Rangaraj Narayanan,Aarti Patel,Sheila Annie Peters,Venkatesh Pilla Reddy,Ming Zheng,Loeckie de Zwart,Maud Beneton,Francois Bouzom,Jun Chen,Yuan Chen,Yumi Cleary,Christiane Collins,Gemma L. Dickinson,Nassim Djebli,Heidi J. Einolf,Iain Gardner,Felix Huth,Faraz Kazmi,Feras Khalil,Jing Lin,Aleksandrs Odinecs,Chirag Patel,Haojing Rong,Edgar Schuck,Pradeep Sharma,Shu Pei Wu,Yang Xu,Shinji Yamazaki,Kenta Yoshida,Malcolm Rowland +33 more
TL;DR: This work provides a perspective on the qualification and verification of physiologically based pharmacokinetic (PBPK) platforms/models intended for regulatory submission based on the collective experience of the Simcyp Consortium members.
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A phase 1 healthy male volunteer single escalating dose study of the pharmacokinetics and pharmacodynamics of risdiplam (RG7916, RO7034067), a SMN2 splicing modifier.
Stefan Sturm,Andreas Günther,Birgit Jaber,Paul Jordan,Nada Al Kotbi,Nikhat Parkar,Yumi Cleary,Nicolas Frances,Tobias Bergauer,Katja Heinig,Heidemarie Kletzl,Anne Marquet,Hasane Ratni,Agnès Poirier,Lutz Müller,Christian Czech,Omar Khwaja +16 more
TL;DR: The objectives of this entry‐into‐human study were to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of risdiplam, and the effect of the strong CYP3A inhibitor itraconazole on the PK of ris diplam in healthy male volunteers.
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Clinical Drug–Drug Interactions Through Cytochrome P450 3A (CYP3A) for the Selective ALK Inhibitor Alectinib
Peter N. Morcos,Yumi Cleary,Elena Guerini,Georgina Dall,Katrijn Bogman,Luigi De Petris,Santiago Viteri,Walter Bordogna,Li Yu,Meret Martin-Facklam,Alex Phipps +10 more
TL;DR: Results from 3 fixed‐sequence studies evaluating drug–drug interactions for alectinib through CYP3A suggest that dose adjustments may not be needed when alect inib is coadministered with CYP 3A inhibitors or inducers or for co Administered CYP2A substrates.
Journal ArticleDOI
Progress in Prediction and Interpretation of Clinically Relevant Metabolic Drug-Drug Interactions: a Minireview Illustrating Recent Developments and Current Opportunities
Stephen Fowler,Peter N. Morcos,Yumi Cleary,Meret Martin-Facklam,Neil Parrott,Michael Gertz,Li Yu +6 more
TL;DR: A highly mechanistic understanding has been developed in the area of CYP-mediated metabolic DDIs enabling the prediction of clinical outcome based on preclinical studies enabling the combination of good quality in vitro data and physiologically based pharmacokinetic modeling to be used to evaluate DDI risk prospectively.
Journal ArticleDOI
Evaluating a physiologically based pharmacokinetic model for prediction of omeprazole clearance and assessing ethnic sensitivity in CYP2C19 metabolic pathway.
Sheng Feng,Yumi Cleary,Neil Parrott,Pei Hu,Cornelia Weber,Yongqing Wang,Ophelia Q. P. Yin,Jun Shi +7 more
TL;DR: The PBPK model within SimCYP adequately predicted omeprazole clearance in Caucasian, Chinese, and Japanese EMs and the 2-fold differences in clearance between Caucasian and Asian EMs may lead to early identification of ethnic sensitivity in clearance and the need for different dosing regimens in a specific ethnic group for substrates of CYP2C19 which can support the rational design of bridging clinical trials.