نتایج جستجو برای: fda criteria
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Hemophagocytic lymphohistiocytosis (HLH) is a syndrome of severe immune activation with macrophage and T-cell infiltration resulting in, multi organ damage. HLH may be primary or secondary in etiology. A high index of suspicion is essential for early diagnosis and treatment. Diagnostic criteria need to be refined and newer treatment options to be explored in order to improve survival especially...
Much has been learned over a short period of time with respect to the corrosion assessment of small medical implant devices. Laboratory testing started with modifications of ASTM G 5 and G 61, which lead to the development of ASTM F 2129, and thence the fine-tuning of that specification to meet the intent of the FDA Guideline for non-clinical tests. The changes in electrochemical testing protoc...
Most practical FPGA designs are limited to finite precision signal processing using fixed-point arithmetic because of the cost and complexity of floating point hardware. While mapping DSP applications onto FPGAs, a DSP algorithm designer, who often develops his applications in MATLAB, must determine the dynamic range and desired precision of input, intermediate and output signals in a design im...
INTRODUCTION The FDA recommends that all quality control tests used for biopharmaceutical product release follow current Good Manufacturing Practices (cGMP's) outlined in the Code of Federal Regulations Title 21. Validation of a quality control test must demonstrate that it provides acceptable performance with respect to accuracy, precision, linearity (characterization of the assay response cur...
The energy-momentum tensor of the Liénard-Wiechert field is split into bound and emitted parts in the Rindler frame, by generalizing the reasoning of Teitelboim applied in the inertial frame [see C. Teitelboim, Phys. Rev. D1 (1970), 1572]. Our analysis proceeds by invoking the concept of “energy” defined with respect to the Killing vector field attached to the frame. We obtain the radiation for...
In 1978, the Food and Drug Administration (FDA), developed a generic anesthesia equipment preuse checklist. The checklist was first released by the FDA in August 1986 and endorsed by the American Association of Nurse Anesthetists on October 18, 1986. The FDA checklist was revised in 1992 to improve the abilities of anesthesia providers to detect machine faults. In the present study, the investi...
s of the NIH-FDA Conference “Biomarkers and Surrogate Endpoints: Advancing Clinical Research and Applications” Abstracts of the NIH-FDA Conference 188s of the NIH-FDA Conference 188
A colloidal water-stable MOF as a broad-range fluorescent pH sensor via post-synthetic modification.
We report for the first time the pH-dependent fluorescence of UiO-66-NH2 across the wide range from 1 to 9. By application of a post-synthetic modification (PSM) diazotisation strategy, we synthesized a new material, UiO-66-N=N-ind, which shows increased chemical stability and enhanced sensing up to pH 12.
On 25 February 2014 Public Citizen filed a petition with the US Food andDrugAdministration (FDA) to immediately require a black box warning about the increased risks of heart attacks and other cardiovascular dangers to the product labels of all drugs containing testosterone presently on the market in the United States. In the petition we pointed out that in a large 27 study meta-analysis, the 1...
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