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On a Stepwise Quantitative Approach for Benefit-Risk Assessment
Therapeutic Innovation & Regulatory Science, 2017The field of structured benefit-risk assessment has evolved rapidly in the last few years with a great deal of regulatory and industry-wide initiatives. The available structured approaches to benefit-risk assessments exhibit and share many common elements in terms of defining the decision problem and therapeutic context, identifying key benefit and ...
Weili, He +3 more
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Benefit-Risk Assessment of Rofecoxib in the Treatment of Osteoarthritis
Drug Safety, 2004NSAIDs are widely used to treat pain and inflammation in osteoarthritis. Their use in this indication is generally intermittent and fluctuates with the intensity of the disease. Nonetheless, success of the therapy is frequently limited by injury to the gastrointestinal mucosa and complications such as bleeding, ulceration and perforation. A careful and
Helmut, Schmidt +2 more
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Benefit-Risk Assessment of Zaleplon in the Treatment of Insomnia
Drug Safety, 2005Insomnia is a heterogeneous, highly prevalent condition that is associated with a high level of psychiatric, physical, social and economic morbidity. The treatment of insomnia involves pharmacological and non-pharmacological interventions. The mainstay of pharmacological treatment of insomnia has been the benzodiazepines, the introduction of which ...
Joseph, Barbera, Colin, Shapiro
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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
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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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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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
A Benefit-Risk Assessment of Caffeine as an Analgesic Adjuvant
Drug Safety, 2001Caffeine has been an additive in analgesics for many years. However, the analgesic adjuvant effects of caffeine have not been seriously investigated since a pooled analysis conducted in 1984 showed that caffeine reduces the amount of paracetamol (acetaminophen) necessary for the same effect by approximately 40%.
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A Benefit-Risk Assessment of Baclofen in Severe Spinal Spasticity
Drug Safety, 2004Baclofen is used for treatment of the spasticity of spinal origin that is a common sequela of spinal cord injury and multiple sclerosis; spasticity occurs in about 50% of patients affected by these disorders. In open-label studies of oral baclofen, the drug improved spasticity in 70-87% of patients; additionally, improvement in spasms was reported in ...
DARIO A, TOMEI, GIUSTINO
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A Benefit-Risk Assessment of Medical Treatment for Uterine Leiomyomas
Drug Safety, 2002The growth of a uterine leiomyoma growth stops and regresses after the menopause suggesting that leiomyoma growth is dependent on ovarian steroids. Therefore, estrogen has received much attention as the major factor responsible for the development of uterine leiomyomas, but progesterone also plays an important role in development of this disease ...
DE LEO, V. +6 more
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