نتایج جستجو برای: fda criteria
تعداد نتایج: 273287 فیلتر نتایج به سال:
BACKGROUND The primary objective of the present study was to examine the drug approval process and the time to approval (tta) for cancer drugs by 3 major international regulatory bodies-Health Canada, the U.S. Food and Drug Administration (fda), and the European Medicines Agency (ema)-and to explore differences in the drug approval processes that might contribute to any disparities. METHODS T...
Sunscreen products are among the most important ways for skin protection against sunburn, early skin aging and skin cancer. Due to existing wide variation of sunscreens, it is necessary to assure their protection ability against the sun damage. Performance assessment of sunscreen products against UVA is expressed by sun UVA protection factor (UVA-PF). Because currently these factors are determi...
Introduction Correlations between in vitro and in vivo data (IVIVC) are often used during pharmaceutical development in order to reduce development time and optimize the formulation. A good correlation is a tool for predicting in vivo results based on in vitro data. IVIVC allows dosage form optimization with the fewest possible trials in man,fixes dissolution acceptance criteria,and can be used...
Some manufacturers of electronic nicotine delivery systems (ENDS) voluntarily carried health warnings in their advertisements. This study examined these voluntary warnings in magazine ads and plotted their trends between 2012 and early 2015. ENDS magazine ads were obtained through Kantar media and warnings were collected from the Chicago Public Library or the Trinkets and Trash surveillance sys...
In response to concerns expressed by applicants regarding inconsistent policies in establishing blend uniformity acceptance criteria to demonstrate adequacy of mix, the FDA Office of Generic Drugs (OGD) issued the draft document Guidance for Industry, ANDAs: Blend Uniformity Analysis (August 1999). Both generic and innovator pharmaceutical companies raised a number of concerns following the pub...
In a recent paper by Coban and colleagues (6), two colorimetric methods for early detection of vancomycin and oxacillin resistance in Staphylococcus aureus were reported. The authors state that the results were compared by calculating essential agreement, absolute agreement, and minor, major, and very major errors, as recommended by the FDA (10). However, in the cited version of the FDA documen...
The support of a set A is the crisp subset of A with nonzero membership grades. Similarly, the core of a set A is the crisp subset of A with membership grade equal to one. So, supp(A) = {x|μA(x) > 0} and core(A) = {x|μA(x) = 1}. (1.1.4) The α-cut Aα of a set A is the crisp subset of A with membership grades of at least α. So, Aα = α-cut(A) = {x|μA(x) ≥ α}. (1.1.5) Note that core(A) = 1-cut(A). ...
Key factors that a hospital finance leader should focus on when considering a potential co-management agreement with physicians, in which the physicians are compensated at fair market value, include: Fee structure of the agreement. The quality metrics that will be used. Benchmarking to set appropriate targets for metrics. Historical performance against the metrics. Legal guidelines regarding su...
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" For age is opportunity no less Than youth itself, though in another dress, And as the evening twilight fades away The sky is filled with stars, invisible by day. " A s cardiovascular specialists, we are caring for a rapidly growing number of older adults despite limited data to guide therapeutics in this population. During the next 25 years, the population age ≥85 years will be more than doub...
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