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Current Use of Physiologically Based Pharmacokinetic modeling in New Medicinal Product Approvals at EMA.
Clin Pharmacol Ther
January 2025
European Medicines Agency, Amsterdam, The Netherlands.
Physiologically Based Pharmacokinetic (PBPK) Models are routinely used in drug development and therefore appear frequently in marketing authorization applications (MAAs) to the European Medicines Agency (EMA). For a model to be a key source of evidence for a regulatory decision, it must be considered qualified for the intended use. Advice on the data expected to allow qualification of a PBPK model or platform is provided in the EMA Guideline on the reporting of PBPK modeling and simulation.
View Article and Find Full Text PDFIntratumor heterogeneity of EGFR expression mediates targeted therapy resistance and formation of drug tolerant microenvironment.
Nat Commun
January 2025
Translational Immunology Research Program (TRIMM), Research Programs Unit, Faculty of Medicine, University of Helsinki, Helsinki, Finland.
Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors are commonly used to treat non-small cell lung cancers with EGFR mutations, but drug resistance often emerges. Intratumor heterogeneity is a known cause of targeted therapy resistance and is considered a major factor in treatment failure. This study identifies clones of EGFR-mutant non-small cell lung tumors expressing low levels of both wild-type and mutant EGFR protein.
View Article and Find Full Text PDFConsumer perceptions of 'traditional doenjang' using a free word association test.
J Sci Food Agric
January 2025
Department of Food Science and Human Nutrition and K-Food Research Center, Jeonbuk National University, Jeonbuk, Korea.
Background: Doenjang (fermented soybean paste) is a traditional Korean ingredient that has long been part of Korean cuisine. Commercial, mass-produced doenjang products are prevalent in the Korean market, and consumer demand for traditionally produced doenjang is steadily decreasing. An understanding of consumers' perceptions of traditional doenjang can serve as a foundation for sales and marketing strategies that are informed by consumer insights.
View Article and Find Full Text PDFUptake of rituximab biosimilars in Medicare and Medicaid in 2019-2022.
Am J Manag Care
December 2024
Department of Health Outcomes Research and Policy, Auburn University Harrison College of Pharmacy, 4306D Walker Building, Auburn University, Auburn, AL 36849-5506. Email:
Objectives: This study evaluated the uptake and costs of 3 biosimilars among Medicare and Medicaid populations for 2019 to 2022: rituximab-abbs (Truxima), rituximab-pvvr (Ruxience), and rituximab-arrx (Riabni).
Study Design: A retrospective, descriptive study.
Methods: Using the annually aggregated, product-level utilization and cost data of biologic and biosimilar rituximab products from CMS drug spending data, total claims and costs (reimbursement and out of pocket) for all rituximab products were identified and extracted from Medicare Part B, Medicare Part D, and Medicaid.
Provider views on vasectomy: cultural, gender, and political elements of Men's decisions to seek publicly funded services.
Front Reprod Health
December 2024
Collaborative Center to Advance Health Services, University of Missouri Kansas City, Kanas City, MO, United States.
Introduction: Evidence suggests a new demand for vasectomies following the Supreme Court's Dobbs v. Jackson Women's Health Organization [597 U.S.
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