Results 261 to 270 of about 2,472,934 (283)
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A Bayesian Approach for Benefit-Risk Assessment
Statistics in Biopharmaceutical Research, 2014An important aspect of the drug evaluation process is to have an integrated benefit-risk assessment to determine, using some quantitative measures, whether the benefit outweighs the risk for the target population. Chuang-Stein et al. proposed a five-category random variable along with three global measures of benefit-risk assessment.
Yueqin Zhao +3 more
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Benefit-Risk Assessment of Sirolimus in Renal Transplantation
Drug Safety, 2005Sirolimus (rapamycin) is a macrocyclic lactone isolated from a strain of Streptomyces hygroscopicus that inhibits the mammalian target of rapamycin (mTOR)-mediated signal-transduction pathways, resulting in the arrest of cell cycle of various cell types, including T- and B-lymphocytes.
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Benefit-Risk Assessments in Dose-Finding Trials
Statistics in Biopharmaceutical Research, 2010The objective of dose-finding trials is to identify the doses that are sufficiently effective and safe for either future late-phase trials or the ultimate patients. Most methodologies for analyzing data from Phase II dose-finding trials mainly focus on finding the effective doses or minimum effective dose through hypothesis testing, while Phase I ...
Hui Quan +5 more
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[Benefit-risk assessment of vaccination strategies].
Medecine sciences : M/S, 2007This article summarises the various stages of the risk/benefit assessment of vaccination strategies. Establishing the awaited effectiveness of a vaccination strategy supposes to have an epidemiologic description of the disease to be prevented. The effectiveness of the vaccine strategy will be thus expressed in numbers of cases, hospitalizations or ...
Thomas, Hanslik, Pierre Yves, Boëlle
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A Benefit-Risk Assessment of Extended-Release Oxybutynin
Drug Safety, 2002Oxybutynin is a muscarinic receptor antagonist, which has been available for a number of years in its original immediate-release (IR) formulation. While oxybutynin IR has proven effective for the treatment of overactive bladder, its extended use can be limited by adverse effects, particularly dry mouth.
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Model-Based Benefit–Risk Assessment: Can Archimedes Help?
Clinical Pharmacology & Therapeutics, 2009In December 2008, the US Food and Drug Administration issued a new draft Guidance for Industry on Diabetes Mellitus--evaluating cardiovascular risk in new antidiabetic therapies to treat Type 2 diabetes. This guidance comes at a time when recent discussions have focused on delineation of cardiovascular risk reduction for new antidiabetic drugs ...
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Benefit-risk assessment of acne therapies
The Lancet, 1997N, Bénéton +4 more
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Benefit-Risk Assessment of Medicines
2015James Leong, Sam Salek, Stuart Walker
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