نتایج جستجو برای: fda criteria
تعداد نتایج: 273287 فیلتر نتایج به سال:
introduction: pharmaceutical companies as well as food and cosmetics manufacturers are legally required to provide a shelf-life label on their products packaging as part of their stability study report. there are different recommended software like r software package and sas which can perform as shelf-life estimating tools for analyzing the data achieved by the stability testing of drugs and va...
In response to concerns raised about the quality of parenteral vancomycin products, the U.S. Food and Drug Administration (FDA) is investigating the product quality of all FDA-approved parenteral vancomycin products available in the United States. Product quality was evaluated independently at two FDA Office of Testing and Research (FDA-OTR) sites. In the next phase of the investigation, being ...
The quality assurance (QA) requirements (i.e., test procedure, acceptance criteria, and testing schedule) for fludeoxyglucose (18)F ((18)F-FDG) injection listed in the U.S. Pharmacopeia (USP); the draft Chemistry, Manufacturing, and Controls (CMC) issued by the U.S. Food and Drug Administration (FDA); and the European Pharmacopeia (EP) were compared. The FDA Modernization Act of 1997 requires t...
Accumulated knowledge of genomic information, systems biology, and disease mechanisms provide an unprecedented opportunity to elucidate the genetic basis of diseases, and to discover new and novel therapeutic targets from the wealth of genomic data. With hundreds to a few thousand potential targets available in the human genome alone, target selection and validation has become a critical compon...
BACKGROUND Carotid artery stenting (CAS) was introduced in the United States nearly a decade ago as a novel treatment of severe carotid stenosis. Voluminous and high-quality prospective data permit analysis of longitudinal trends in CAS outcomes. METHODS Outcomes from all prospective trials with the Food and Drug Administration (FDA) oversight from 2000-2011 were reviewed, as were the subset ...
abstract: research purpose: the purpose of this research is to identify academic databases assessment factors and criteria at law and political science majors. the necessity of this research is to distinguish academic databases assessment factors and criteria and to identify the most important ones and rank them in order to select an appropriate database according to students’ and faculty memb...
background recombinant activated factor vii (rfviia; novoseven® rt, novo nordisk, bagsvaerd, denmark) is a synthetic pro-coagulation factor derived from hamster kidney cells. objectives the purpose of this study was to evaluate the prescribing patterns of recombinant factor viia (rfviia) at a single, tertiary care pediatric hospital by indication of usage and dose administered. materials and me...
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