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A 2024 Update on US FDA Implementation of Partial Area Under the Curve Into Bioavailability and Bioequivalence Assessments.
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Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Comparisons of maximum drug concentration (C) and total area under the concentration vs. time curve (AUC) may be inadequate for bioavailability (BA)/bioequivalence (BE) assessments in cases where the shape of the pharmacokinetic (PK) profile of a drug impacts the clinical performance. In such cases, partial area under the concentration vs.
View Article and Find Full Text PDFSuccessful Management of Disseminated Intravascular Coagulation in Metastatic Castrate-Resistant Prostate Cancer With Lutetium-177: A Case Report and Review of the Literature.
Cureus
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Department of Internal Medicine, Division of Hematology and Oncology, University of Texas Southwestern Medical Center, Dallas, USA.
Disseminated intravascular coagulation (DIC) is a hematological disorder characterized by the abnormal activation of the coagulation system, which leads to widespread clotting and subsequent consumption coagulopathy. DIC is often associated with the progression of prostate cancer and can be a life-threatening condition. In this case report, we present a patient with recurrent DIC in the setting of advanced prostate cancer.
View Article and Find Full Text PDFRecent Trends in Medical Management of Endometriosis.
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Nowrosjee Wadia Maternity Hospital, Mumbai, India.
Endometriosis affects about 10 percent women in the reproductive age group globally and approximately 42 million in India. Managing the patient's pain symptoms associated with endometriosis appears to be the cornerstone in endometriosis disease management. The ideal medical treatment in endometriosis would be suppressing estradiol enough to alleviate symptoms of endometriosis but maintain sufficient levels to mitigate hypoestrogenic side effects.
View Article and Find Full Text PDFUnintentional exposure to leuprolide acetate during early pregnancy with a huge intramural myoma.
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Department of Medicine, University of Hawai'i at Mānoa John A Burns School of Medicine, Honolulu, Hawaii, USA.
Leuprolide acetate is commonly used to reduce the size of myomas before surgery. Initially, it stimulates pituitary gonadotropin secretion, followed by sustained suppression of gonadal function. However, the impact on pregnancy outcomes from inadvertent exposure remains unclear.
View Article and Find Full Text PDFPSMA-PET/CT Findings in Patients With High-Risk Biochemically Recurrent Prostate Cancer With No Metastatic Disease by Conventional Imaging.
JAMA Netw Open
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Ahmanson Translational Theranostics Division, Department of Molecular and Medical Pharmacology, David Geffen School of Medicine, University of California, Los Angeles.
Importance: The phase 3 randomized EMBARK trial evaluated enzalutamide with or without leuprolide in high-risk nonmetastatic hormone-sensitive prostate cancer. Eligibility relied on conventional imaging, which underdetects metastatic disease compared with prostate-specific membrane antigen-positron emission tomography (PSMA-PET).
Objective: To describe the staging information obtained by PSMA-PET/computed tomography (PSMA-PET/CT) in a patient cohort eligible for the EMBARK trial.
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