نتایج جستجو برای: fda criteria
تعداد نتایج: 273287 فیلتر نتایج به سال:
conclusions it is clear that new antimicrobials are needed to treat mdr a. baumannii. polymyxins and tigecycline are among the fewrnantibiotics available to treat infections with these bacteria but little was known about the antimicrobial activity of these agents. thernpresent study provided valuable information about the effects of the above mentioned drugs that can be used for health policy. ...
BACKGROUND Human epidermal growth factor receptor 2 (HER2) is one of the known oncogenes in urothelial carcinoma. However, the association between HER2 and the prognosis of upper urinary tract urothelial carcinoma (UUTUC) has not yet been fully clarified. The aim of this study was to evaluate HER2 expression using the United States Food and Drug Administration (FDA) criteria and American Societ...
The 2007 American Society of Clinical Oncology and College of American Pathologists (ASCO/CAP) joint guidelines defined criteria for HER2 positivity of tumors that modified those of the US Food and Drug Administration (FDA), causing some confusion and uncertainty among clinicians. Using data from the HER2-positive breast cancer adjuvant trial N9831, we compared eligibility for patients who met ...
Biosimilars, although not identical to their originator product, are expected to become essential in reducing health care costs and improving access to lifesaving drugs. The FDA must find a way to balance rigorous testing to ensure quality, as is done for generic chemical drugs, with providing a cost-efficient way to expedite approvals of these products.
The U.S. Food and Drug Administration (FDA) uses regulatory action criteria for filth and extraneous materials to evaluate adulteration of food products. The criteria are organized into three categories: health hazards, indicators of insanitation, and natural or unavoidable defects. The health hazard category includes criteria for physical, chemical, and microbiological hazards associated with ...
BACKGROUND In 2006, a US Food and Drug Administration (FDA) alert warned about the potential life-threatening risk of serotonin syndrome when triptans are used in combination with selective serotonin reuptake inhibitors (SSRIs) or selective serotonin/norepinephrine reuptake inhibitors (SNRIs). This American Headache Society Position Paper further reviews the available evidence of the potential ...
Clinical investigators invoke a number of specific regulatory requirements if their study includes use of a pharmaceutical agent. Studies using a drug that has not been approved by the Food and Drug Administration (FDA) or for indications not in the approved labeling may require filing an Investigational New Drug (IND) application with the FDA. If a study meets specific regulatory exemption cri...
This article evaluates the oversight of drugs and medical devices by the U.S. Food and Drug Administration (FDA) using an integration of public policy, law, and bioethics approaches and employing multiple assessment criteria, including economic, social, safety, and technological. Criteria assessment and expert elicitation are combined with existing literature, case law, and regulations in an in...
In the 2012 Food and Drug Administration (FDA) draft guidance on drug-drug interactions (DDIs), a new molecular entity that inhibits Pglycoprotein (P-gp) may need a clinical DDI study with a P-gp substrate such as digoxin when themaximum concentration of inhibitor at steady state divided by IC50 ([I1]/IC50) is ‡0.1 or concentration of inhibitor based on highest approved dose dissolved in 250 ml...
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