Results 131 to 140 of about 11,033 (240)
British Journal of Pharmacology, Volume 183, Issue 10, Page 2482-2496, May 2026.Background The activity of CYP2C9, an important drug metabolism enzyme, is subject to the impact of genetic polymorphism. The single nucleotide polymorphism *3 is significantly associated with the increased exposure of CYP2C9 substrates. In addition, metabolic enzyme inhibitors such as fluconazole may also increase the drug exposure of CYP2C9 ...
Shen Cheng +5 more
wiley +1 more source
Clinical and Translational Science, Volume 19, Issue 5, May 2026.ABSTRACT Model‐informed drug development (MIDD) has grown from a constellation of methodological advances to a profound reorientation of how evidence is generated, evaluated, integrated, and leveraged in both drug development and regulatory decision‐making.
Issam Zineh
wiley +1 more source
PharmaceuticsThe antiparasitic drug ivermectin is approved for persons > 15 kg in the US and EU. A pharmacometric (PMX) population model with clinical PK data was developed (i) to characterize the effect of the patient-friendly ivermectin formulation CHILD-IVITAB on ...
Klervi Golhen +8 more
doaj +1 more source
Alternative Dosing Regimens of Tislelizumab Using a Pharmacometrics Model‐Based Approach
Clinical and Translational ScienceTislelizumab 200 mg once every 3 weeks (Q3W) is approved for the treatment of multiple cancers. We used a model‐based approach to propose three alternative dosing regimens, 150 mg Q2W, 300 mg Q4W, and 400 mg Q6W, with the aims of providing flexible ...
Ahsan Rizwan +13 more
doaj +1 more source
Clinical and Translational Science, Volume 19, Issue 5, May 2026.ABSTRACT Reliable biomarkers that enable noninvasive, longitudinal assessment of disease activity and therapeutic response remain a major unmet need in inflammatory bowel disease (IBD). While colonic biopsies are the gold standard for evaluating mucosal inflammation, their invasive nature and limited spatial and temporal resolution constrain their ...
Mohamed Hassanein +8 more
wiley +1 more source
Optimizing Oligonucleotide Therapeutics: A Model‐Informed Drug Development Perspective
Clinical and Translational Science, Volume 19, Issue 5, May 2026.ABSTRACT Oligonucleotide therapies have emerged as a powerful therapeutic class, providing novel solutions for diverse diseases through antisense oligonucleotides (ASOs), small interfering RNAs (siRNAs), and aptamers that specifically target and modulate gene expression or protein function. However, oligonucleotide development faces distinct challenges,
Ye Yuan +7 more
wiley +1 more source
Pharmacometrics and/or Systems Pharmacology [PDF]
CPT: Pharmacometrics & Systems Pharmacology, 2019 openaire +3 more sources
Advancing Pharmacoequity in Low‐ and Middle‐Income Countries via Model Informed Drug Development
Clinical and Translational Science, Volume 19, Issue 5, May 2026.ABSTRACT Across low‐ and middle‐income countries (LMICs) inequities in access to safe, effective medicines persist due to limited regulatory capacity, inadequate financing, and insufficient local data. Regulatory authorities are engaging with model‐informed drug development (MIDD), but uneven technical readiness and resource gaps limit uptake ...
Henry Enzama +5 more
wiley +1 more source
Clinical and Translational Science, Volume 19, Issue 5, May 2026.ABSTRACT The NLRP3 inflammasome is a central mediator of innate immunity and a key driver of inflammatory and neurodegenerative diseases. VENT‐02 is orally bioavailable, central nervous system‐penetrant, selective small‐molecule inhibitor of NLRP3. This first‐in‐human, randomized, double‐blind, placebo‐controlled study assessed the safety, tolerability,
Lisanne C. A. Smidt +14 more
wiley +1 more source