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Leveraging Model-Based Simulations to Optimize Extended Dosing of Leuprolide 6-Month Intramuscular Depot Formulation.
Eur J Drug Metab Pharmacokinet
January 2025
School of Pharmacy, National Defense Medical Center, Taipei, Taiwan.
Background And Objective: A gonadotropin-releasing hormone (GnRH) agonist such as leuprolide is widely used to achieve sustained suppression of testosterone levels, which play a critical role in the treatment of prostate cancer. Recent advances in drug delivery systems have led to the development of long-acting depot formulations, such as the 6-month intramuscular (IM) leuprolide formulation, which aim to simplify dosing and improve convenience for both patients and healthcare providers. Exploring extended dosing intervals for such formulations represents a promising approach to further optimize treatment regimens, potentially balancing efficacy with patient-centered care.
View Article and Find Full Text PDFDistribution and correlates of long-acting injectable antipsychotic use among community mental health center patients.
Psychiatry Res
January 2025
South Carolina Department of Mental Health, 220 Executive Dr, Greer, SC 29651, United States; Department of Neuropsychiatry and Behavioral Science, University of South Carolina School of Medicine, 15 Medical Park, Suite 301, Columbia, SC 29203, United States.
Although long-acting injectable antipsychotics (LAIs) are an important pharmaceutical option in the management of schizophrenia and related disorders, little is known about patient characteristics related to LAI use in real-world outpatient settings. We analyzed electronic medical records from 41,401 patients who received psychiatric services from one of 16 regional mental health centers operated by the South Carolina Department of Mental Health in 2022. We compared the use of first- and second-generation LAIs and oral antipsychotics by sociodemographic (age, gender, race/ethnicity, zip code, payment source) and clinical characteristics (psychiatric diagnoses, service use).
View Article and Find Full Text PDFThigh Injections of Cabotegravir + Rilpivirine in Virally Suppressed Adults With Human Immunodeficiency Virus Type 1: A Substudy of the Phase 3b ATLAS-2M Study.
Clin Infect Dis
January 2025
ViiV Healthcare, Durham, North Carolina, USA.
Article Synopsis
- CAB + RPV is the first long-acting HIV treatment regimen using thigh injections, showing promising results in maintaining viral suppression.
- The study involved 118 participants and compared pharmacokinetic changes and tolerability between thigh and gluteal injections, finding no significant differences in effectiveness.
- Results indicated that a majority of participants preferred thigh injections, with potential plans for more flexible dosing schedules to enhance treatment convenience.
The effects of growth hormone on the outcomes of fertilization and embryo transfer in age-grouped patients with decreased ovarian reserve: a prospective cohort study.
Front Endocrinol (Lausanne)
January 2025
Reproductive Medicine Center, Sichuan Provincial Women's and Children's Hospital, The Affiliated Women's and Children's Hospital of Chengdu Medical College, Chengdu, China.
Background: Growth hormone (GH) could improve the outcomes of fertilization and embryo transfer (IVF-ET) in patients with decreased ovarian reserve (DOR), but which age group will benefit the most has remained controversial. This study aims to explore the outcome of IVF-ET among differently aged patients with DOR treated with GH.
Methods: A total of 846 patients with DOR undergoing IVF-ET from May 2018 to June 2023 at the Reproductive Medicine Center of Sichuan Provincial Women's and Children's Hospital were prospectively enrolled.
Leveraging Model Master Files for Long-Acting Injectables.
Pharm Res
January 2025
Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, , MD, 20993, USA.
The U.S. Food and Drug Administration (FDA) and the Center for Research on Complex Generics (CRCG) hosted a public workshop on May 2-3, 2024, titled "Considerations and Potential Regulatory Applications for a Model Master File (Lachaine et al Can J Psychiatry.
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