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Cell-Based Meat Safety and Regulatory Approaches: A Comprehensive Review.
Food Sci Anim Resour
January 2025
Department of Food Science and Biotechnology, College of Life Science, Sejong University, Seoul 05006, Korea.
Cell-based meat (CBM) technology is a highly promising alternative to traditional animal agriculture, with considerable advantages in terms of sustainability, animal welfare, and food security. Nonetheless, CBM's successful commercialization is dependent on efficiently dealing with several critical concerns, including ensuring biological, chemical, and nutritional safety as well as navigating the global regulatory framework. To ensure CBM's biological safety, detecting and mitigating any potential hazards introduced during the manufacturing process is crucial.
View Article and Find Full Text PDFA Threshold Technique Study to Understand Patient Preference for Smooth Versus Textured Breast Implants.
Plast Reconstr Surg Glob Open
January 2025
U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health, Silver Spring, MD.
Background: Breast implant surfaces are categorized as smooth or textured. Compared with smooth implants, textured surface implants have a higher risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) but may have a lower risk of capsular contracture (CC). This study aimed to quantify whether survey respondents would be willing to accept a higher risk of BIA-ALCL in exchange for the potential reported benefits of textured breast implants.
View Article and Find Full Text PDFExcipients in drug delivery systems: A comprehensive review of approved inactive ingredients for human ophthalmic formulations.
Eur J Pharm Biopharm
January 2025
Inserm UMRS_1138, Team 1, Physiopathology of ocular diseases: Therapeutic Innovations at Centre de Recherche des Cordeliers, Paris, France, 75006; Ophthalmopole at Hôpital Cochin, Paris, France; Sorbonne Paris Cité, UMRS_1138, France. Electronic address:
Pharmaceutical excipients, commonly known as inactive ingredients, encompass any substance aside from the active ingredient that fulfills a distinct and vital role in a formulation. Their purpose is to enhance specific characteristics, whether associated with the performance of the formulation or aspects related to patient comfort, safety, and acceptability. Because of the limited toxicity studies provided, and the several allergic and toxic side effects that have been reported throughout the years, it is not trivial for the regulatory agencies to approve inactive ingredients for human use.
View Article and Find Full Text PDFComparing quantitative imaging biomarker alliance volumetric CT classifications with RECIST response categories.
Radiol Adv
January 2025
Department of Radiology, Duke University Medical Center, Durham, NC 27710, United States.
Purpose: To assess agreement between CT volumetry change classifications derived from Quantitative Imaging Biomarker Alliance Profile cut-points (ie, QIBA CTvol classifications) and the Response Evaluation Criteria in Solid Tumors (RECIST) categories.
Materials And Methods: Target lesions in lung, liver, and lymph nodes were randomly chosen from patients in 10 historical clinical trials for various cancers, ensuring a balanced representation of lesion types, diameter ranges described in the QIBA Profile, and variations in change magnitudes. Three radiologists independently segmented these lesions at baseline and follow-up scans using 2 software tools.
A Real-World Data Analysis of Alglucosidase Alfa in the FDA Adverse Event Reporting System (FAERS) Database.
Drugs R D
January 2025
Department of Pediatric Intensive Care Unit, Shandong, Shandong Provincial Hospital Affiliated to Shandong First Medical University, 324 Jingwu Road, Ji'nan, Shandong, China.
Background And Objective: Alglucosidase alfa for injection is used as an enzyme replacement therapy for the treatment of Pompe disease. The safety profile of alglucosidase alfa-associated adverse events requires a comprehensive evaluation. In this study, we aimed to identify drug safety alert signals and investigate the real-world safety of alglucosidase alfa to guide clinical decision making and optimize the risk-benefit balance.
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