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http://dx.doi.org/10.1093/ecco-jcc/jjw141 | DOI Listing |
JMIR Res Protoc
September 2025
Service of Clinical Pharmacology, Department of Medicine, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
Background: Janus kinase inhibitors (JAKIs) are small molecules used orally to treat inflammatory and hematological disorders. They have demonstrated impressive efficacy across multiple indications. However, concerns have emerged regarding their safety profile.
View Article and Find Full Text PDFJ Clin Pharmacol
September 2025
Daiichi Sankyo Inc., Basking Ridge, NJ, USA.
Valemetostat is a dual inhibitor of EZH2/1 approved in Japan for the treatment of relapsed/refractory (R/R) adult T-cell lymphoma/leukemia (ATLL) and R/R peripheral T-cell lymphoma (PTCL). It is administered orally once daily (QD) at 200 mg. Here, we present comprehensive population pharmacokinetic (PPK) and exposure-response (ER) analyses of valemetostat.
View Article and Find Full Text PDFJ Clin Pharmacol
September 2025
Clinical Pharmacology, Modeling and Simulation, Amgen Inc., South San Francisco, CA, USA.
Oncolytic viruses are an emerging class of immunotherapies for cancer treatment. Talimogene laherparepvec (T-VEC) is a first-in-class oncolytic virus approved globally for advanced melanoma. Herein, we describe the quantitative clinical pharmacology aspects of T-VEC that supported the development of this unique therapy.
View Article and Find Full Text PDFJ Chromatogr B Analyt Technol Biomed Life Sci
August 2025
Department of Pharmacy, China-Japan Friendship Hospital, Beijing 100029, PR China. Electronic address:
Crizotinib, alectinib, and lorlatinib are tyrosine kinase inhibitors used sequentially in non-small cell lung cancer (NSCLC) therapy. Therapeutic drug monitoring (TDM) is valuable during sequential treatment, enabling simultaneous quantification. Consequently, an analytical method capable of multiplexing these three compounds into a single assay is highly applicable for routine TDM.
View Article and Find Full Text PDFClin Pharmacol Drug Dev
September 2025
Clinical Pharmacology & Pharmacometrics, BeOne Medicines Ltd, San Carlos, CA, USA.
Zanubrutinib is a next-generation Bruton tyrosine kinase inhibitor approved for treating B-cell malignancies. Two phase 1 studies evaluated a new 160-mg zanubrutinib tablet versus 80-mg capsules. In study BGB-3111-115 (n = 43), a randomized 3-period crossover trial, relative bioavailability and food effects were assessed.
View Article and Find Full Text PDF