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Dose Ranging in Pediatric Drug Development Trials Submitted to the US FDA 2012-2020.
J Clin Pharmacol
March 2025
Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Dose selection is a critical process within pediatric drug development and dose-ranging studies are integral to establish a reasonable dose. The objective of this analysis was to examine the dose-ranging trials utilized in pediatric drug development and to determine (1) the dose-ranging strategies that were used in all available pediatric dose-ranging studies, (2) the success of achieving pediatric labeling in those submissions to the US Food and Drug Administration, and (3) ethical aspects of providing a prospect of direct benefit to pediatric patients in dose-ranging studies. Of the 275 programs that previously surveyed pediatric drug development programs from 2012 to 2020, it was determined that dose-ranging studies were used for 97 (35.
View Article and Find Full Text PDFChanges in the blood cyclosporine level after switching from voriconazole to isavuconazole in a patient with aplastic anemia: insights from physiologically based pharmacokinetic model simulation and the Adverse Event Reporting System database study.
Front Microbiol
February 2025
Department of Pharmacy, Mie University Hospital, Mie, Japan.
Introduction: Isavuconazole, a broad-spectrum triazole approved by the United States Food and Drug Administration (FDA) in 2015, moderately inhibits cytochrome P450 3A4. Although antifungal agents are often used concomitantly with cyclosporine, the effect of switching from voriconazole to isavuconazole on the blood cyclosporine level remains unclear.
Case: A 63-year-old Japanese male was administered oral cyclosporine (10:00 and 21:00) for severe aplastic anemia.
Role of PSMA PET/CT in imaging and management of prostate cancer.
Curr Opin Oncol
February 2025
Department of Diagnostic Radiology and Nuclear Medicine.
Purpose Of Review: In the era of precision medicine, the introduction of FDA-approved prostate-specific membrane antigen (PSMA) targeting tracers has revolutionized prostate cancer imaging. These tracers enable functional positron emission tomography (PET) imaging, allowing for precise identification of the location and extent of prostate cancer spread. This review serves as a practical guide for multidisciplinary teams caring for prostate cancer patients, outlining the current approved uses of PET imaging with PSMA tracers and exploring its future applications.
View Article and Find Full Text PDFBuprenorphine's Effect on the Human Immune System and Inflammation.
Clin Transl Sci
March 2025
Department of Psychiatry & Psychology, Mayo Clinic, Rochester, Minnesota, USA.
Opioid use disorder is a persistent epidemic despite several FDA-approved medications for its treatment. While the pathogenesis of opioid use disorder has been classically attributed to dopamine pathways in the brain, there is emerging evidence and interest surrounding the role of inflammation and inflammatory signaling in its development and treatment. Buprenorphine has become the most prescribed medication for opioid use disorder, largely due to its ease of access and tolerability.
View Article and Find Full Text PDFUnveiling WHIM syndrome: Mavorixafor's Emerging Role in Immune Restoration and Therapy.
Clin Exp Immunol
March 2025
Hematology/Oncology Fellow, Medical College of Wisconsin, Milwaukee, WI.
WHIM syndrome is a rare autosomal dominant immunodeficiency disorder and is an abbreviation formed from the initial letters of its main clinical presentations: Warts, Hypogammaglobulinemia, Infections, and Myelokathexis. It stems mainly from mutations where there is a gain of function in the chemokine receptor CXCR4, which is extensively located on leukocytes, and significantly affects the balance of the immune system. Many therapeutic strategies have been widely explored for several years for this immunodeficiency disorder.
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