Systems validation: application to statistical programs [PDF]
, 2005 BACKGROUND: In 2003, the United States Food and Drug Administration (FDA) released a guidance document on the scope of "Part 11" enforcement. In this guidance document, the FDA indicates an expectation of a risk-based approach to determining which ...
D Moher +5 more
core +3 more sources
Food and Drug Administration Regulation of Food Safety [PDF]
, 2011 Food-borne illness remains a major public health challenge in the United States, causing an estimated 48 million illness episodes and 3000 deaths annually.
Gostin, Lawrence O., Stewart, Katie F.
core +3 more sources
DLI-IT: a deep learning approach to drug label identification through image and text embedding
BMC Medical Informatics and Decision Making, 2020 Background Drug label, or packaging insert play a significant role in all the operations from production through drug distribution channels to the end consumer.
Xiangwen Liu +5 more
doaj +1 more source
Transplanting islet cells can fix brittle diabetes. Why isn’t it available in the U.S.? [PDF]
CellR4, 2019 Type 1 diabetes, which affects 1.25 million American children and adults, and more than 20 million people around the world, is a challenging chronic disease caused by the body’s inability to make insulin.
C. Ricordi, A. Japour
doaj +1 more source
Frontiers in Microbiology, 2014 Rapid molecular typing methods are important tools in surveillance and outbreak investigations of human Salmonella infections. Here we described the development of a three-genes PCR-RFLP typing method for the differentiation of Salmonella species ...
Angel Antonio Soler-Garcia +3 more
doaj +1 more source
The continued value of disk diffusion for assessing antimicrobial susceptibility in clinical laboratories: Report from the Clinical and Laboratory Standards Institute Methods Development and Standardization Working Group [PDF]
, 2018 Expedited pathways to antimicrobial agent approval by the U.S. Food and Drug Administration (FDA) have led to increased delays between drug approval and the availability of FDA-cleared antimicrobial susceptibility testing (AST) devices.
Burnham, Carey-Ann D +6 more
core +2 more sources
Evaluation of Methods for Transient Transfection of a Murine Macrophage Cell Line, RAW 264.7
BioTechniques, 1999 Monocyte/macrophage cell lines are fastidious cells commonly used in transient transfection experiments. In the course of a study of gene regulation by lipopolysaccharide (LPS), we have compared several methods for DNA-mediated cell transfection to ...
C.D. Thompson +4 more
doaj +1 more source
Authentication test of seasoning food materials made from turmeric using real-time PCR
Ho Chi Minh City Open University Journal of Science - Engineering and Technology, 2023 The authentication test for spices made from turmeric using real-time. This study aimed to determine whether the spice ingredients claimed to be made from turmeric actually contain turmeric, as asserted by the product.
Alfi Sophian, Ratna Purwaningsih
doaj +1 more source
Frontiers in Neurology, 2014 Neural progenitor cell expansion is critical for normal brain development and an appropriate response to injury. During the brain growth spurt, exposures to general anesthetics which either block the N-methyl D-aspartate receptor or enhance the γ ...
Shuliang eLiu +9 more
doaj +1 more source
SENTINEL SYSTEM – electronic system for collecting real-world data
Реальная клиническая практика: данные и доказательства, 2022 The need to use more and more data to generate evidence in response to new challenges in clinical medicine requires a specific response from the healthcare system. The high pace of development of medicine, the acceleration of the development of new drugs
E. O. Eremenko, M. I. Baranova
doaj +1 more source