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Benefit-risk assessment for binary diagnostic tests
Journal of Biopharmaceutical Statistics, 2019In diagnostic device evaluation, it is important to have an integrated benefit-risk (BR) assessment for safety and effectiveness, which is not same as the assessment for drugs and therapeutic devices. Correct diagnosis does not lead to direct clinical outcome such as longer survival, release of symptoms, tumor shrinkage, etc.; but leads to the proper ...
Tianyu, Bai +3 more
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2017
While medicines have been assessed in terms of their benefits and risks since health authorities started requiring clinical studies in the 1960s, only recently more formal approaches for conducting benefit–risk evaluations have emerged. Both the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) are in the process of ...
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While medicines have been assessed in terms of their benefits and risks since health authorities started requiring clinical studies in the 1960s, only recently more formal approaches for conducting benefit–risk evaluations have emerged. Both the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) are in the process of ...
openaire +1 more source
1979
Those who organized the program for this symposium have, indeed, done a skillful job. Scientific presentations on previous days focused attention on exciting new technologies and their obvious- utilities. Speakers and discussants led us onto a mountain of expectation.
openaire +1 more source
Those who organized the program for this symposium have, indeed, done a skillful job. Scientific presentations on previous days focused attention on exciting new technologies and their obvious- utilities. Speakers and discussants led us onto a mountain of expectation.
openaire +1 more source
Bromazepam: Acute benefit-risk assessment in general practice
Current Medical Research and Opinion, 1984A study was carried out in general practice to assess the benefit-risk ratio of a single new drug, bromazepam, prior to marketing. Analysis of data supplied by 393 participating doctors on 3101 patients showed that bromazepam, in a dose range of 3 mg to 9 mg daily in divided doses, was effective as an anxiolytic in 79% of the patients and that the ...
C, Hallett, B C, Dean
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Benefit-Risk Assessment of Raloxifene in Postmenopausal Osteoporosis
Drug Safety, 2005Raloxifene, a nonsteroidal benzothiophene, is a second-generation selective estrogen receptor modulator (SERM) that is an antiresorptive agent. Raloxifene is a non-hormonal agent that binds to the estrogen receptor and results in estrogen agonist effects on bone and the cardiovascular system and estrogen antagonist effects on endometrial and breast ...
Ann, Cranney, Jonathan D, Adachi
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Benefit-Risk Assessment of Tegaserod in Irritable Bowel Syndrome
Drug Safety, 2004Tegaserod is a new partial agonist of serotonin 5-HT4 receptors specifically developed for the treatment of nondiarrhoeal forms of irritable bowel syndrome (IBS). Among its various effects is the stimulation of the peristaltic reflex with its promotility action appearing to affect the whole length of the gastrointestinal tract.
Lea, Richard, Whorwell, Peter J.
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BRAFO tiered approach for benefit–risk assessment of foods
Food and Chemical Toxicology, 2012BRAFO stands for Benefit-Risk Analysis for Foods. This European Commission funded project aims at developing a framework that allows quantitative comparison of human health risks and benefits of foods and food compounds based on a common scale of measurement.
Hoekstra J +13 more
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A Benefit-Risk Assessment of Basiliximab in Renal Transplantation
Drug Safety, 2004Interleukin-2 (IL-2) and its receptor (IL-2R) play a central role in T lymphocyte activation and immune response after transplantation. Research on the biology of IL-2R allowed the identification of key signal transduction pathways involved in the generation of proliferative and antiapoptotic signals in T cells.
BOGGI, UGO +7 more
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Benefit-risk assessment—safety perspective
Abstract Benefit-risk assessment is a continuous process, using a variety of sources of information. The concepts that apply for the evaluation of a new safety signal are described and the content of the benefit-risk evaluation report provided.Phil Ambery +2 more
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Bayesian Approach to Personalized Benefit-Risk Assessment
Statistics in Biopharmaceutical Research, 2016ABSTRACTBenefit-risk assessment is critical in evaluating the effectiveness of a new drug before and after the approval. Some benefit-risk measures depend on the probabilities of benefit-risk categories in which the subject-level benefit and risk outcomes are characterized.
Shiqi Cui, Yueqin Zhao, Ram C. Tiwari
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