Clinical pathology testing in nonclinical toxicity and safety studies is an important part of safety assessment. In recent years, clinical laboratory testing has rapidly expanded and improved. Some government regulatory agencies provide guidelines for clinical pathology testing in nonclinical toxicity and safety studies. To improve these testing guidelines and the resultant safety assessments, the American Association for Clinical Chemistry's Division of Animal Clinical Chemistry and the American Society for Veterinary Clinical Pathology formed a joint committee to provide expert recommendations for clinical pathology testing of laboratory species involved in subchronic and chronic nonclinical toxicity and safety studies. These recommendations include technical recommendations on blood collection techniques and hematology, serum chemistry, and urinalysis tests.
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http://dx.doi.org/10.1177/0192623392020003217 | DOI Listing |
J Clin Invest
January 2025
Department of Nuclear Medicine, Peking University Cancer Hospital & Institute, Beijing, China.
Background: B7-H3 or CD276 is notably overexpressed in various malignant tumor cells in humans, with extremely high expression rates. The development of a radiotracer that targets B7-H3 may provide a universal tumor-specific imaging agent and allow the noninvasive assessment of the whole-body distribution of B7-H3-expressing lesions.
Methods: We enhanced and optimized the structure of an affibody (ABY) that targets B7-H3 to create the radiolabeled radiotracer [68Ga]Ga-B7H3-BCH, and then, we conducted both foundational experiments and clinical translational studies.
Transl Vis Sci Technol
January 2025
Department of Biomedical Engineering, Faculty of Engineering, Mahidol University, Nakhon Pathom, Thailand.
Purpose: The purpose of this study was to develop a deep learning approach that restores artifact-laden optical coherence tomography (OCT) scans and predicts functional loss on the 24-2 Humphrey Visual Field (HVF) test.
Methods: This cross-sectional, retrospective study used 1674 visual field (VF)-OCT pairs from 951 eyes for training and 429 pairs from 345 eyes for testing. Peripapillary retinal nerve fiber layer (RNFL) thickness map artifacts were corrected using a generative diffusion model.
Transl Vis Sci Technol
January 2025
Beijing Institute of Ophthalmology, Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University, Beijing, China.
Purpose: To clarify the clinical and imaging characteristics of Candida keratitis using in vivo confocal microscopy (IVCM) for improved early diagnosis and management.
Methods: A retrospective study of 40 patients with Candida keratitis at Beijing Tongren Hospital from January 2015 to December 2023 was conducted. Data included demographics, risk factors, clinical assessments, lab tests, and IVCM images.
JAMA Ophthalmol
January 2025
Truhlsen Eye Center, Department of Ophthalmology and Visual Sciences, University of Nebraska Medical Center, Omaha.
Importance: Randomized clinical trials have shown the safety and efficacy of faricimab as a novel vascular endothelial growth factor and angiopoietin-2 inhibitor in the treatment of neovascular age-related macular degeneration (nAMD) and macular edema of various etiologies. However, more rare adverse events may not be considered in clinical trials.
Objective: To describe 3 eyes that developed irreversible vision loss following initial mild intraocular inflammation (IOI) to faricimab.
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