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Estimand in benefit-risk assessment
Journal of Biopharmaceutical Statistics, 2023ICH E9(R1) introduces the estimand framework to strengthen dialogues between sponsors and regulators during drug development. A well-structured benefit-risk assessment (BRA) framework also intends to facilitate communication among stakeholders. However, the estimand in ICH E9(R1) is written mainly from the perspective of a single measure of treatment ...
Xinru, Ren +3 more
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Implementing Benefit-Risk Assessment for the Periodic Benefit-Risk Evaluation Report
Therapeutic Innovation & Regulatory Science, 2016In 2012, the International Conference on Harmonisation (ICH) E2C (R1) guideline for periodic safety update reporting (PSUR) for medicines was revised. Several new concepts that expanded the scope of the report were added, including a new section focused on benefits and an additional section focused on integrated benefit-risk (B-R) assessment.
Margaret R, Warner +2 more
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A Benefit-Risk Assessment of Sibutramine in the Management of Obesity
Drug Safety, 2003Obesity is a multifactorial, chronic disorder that has reached epidemic proportions in most industrialised countries and is threatening to become a global epidemic. Clinical management of obese patients is complex and serious doubts have arisen with regard to safety and efficacy of drug therapy.
Enzo Nisoli, Michele Carruba
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Planning Benefit-Risk Assessments Using Visualizations
Therapeutic Innovation & Regulatory Science, 2023A Benefit Risk Assessment Plan (BRAP) describes the assessments planned to determine whether the benefits of an investigational drug outweigh the risks. The plan can have two sections, one with timelines for aligning resources with decision milestones and the other for pre-specifying assessments for decision milestones. Regulatory guidance recommends a
Michael W. Colopy +2 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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Journal of the American Oil Chemists' Society, 1978
AbstractA systematic approach to benefit/risk assessment is presented which recognizes (a) the potentially broad exposure of humans and the environment to soap and detergent materials, (b) current regulatory requirements, and (c) the desirability for making these assessments at various stages of product development to minimize both unnecessary testing ...
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AbstractA systematic approach to benefit/risk assessment is presented which recognizes (a) the potentially broad exposure of humans and the environment to soap and detergent materials, (b) current regulatory requirements, and (c) the desirability for making these assessments at various stages of product development to minimize both unnecessary testing ...
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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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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 Antileukotrienes in the Management of Asthma
Drug Safety, 2003Antileukotrienes are a relatively new class of anti-asthma drugs that either block leukotriene synthesis (5-lipoxygenase inhibitors) like zileuton, or antagonise the most relevant of their receptors (the cysteinyl leukotriene 1 receptor [CysLT1]) like montelukast, zafirlukast or pranlukast. Hence, their major effect is an anti-inflammatory one.
Luis, García-Marcos +2 more
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Benefit–Risk Assessment of Diacerein in the Treatment of Osteoarthritis
Drug Safety, 2015Osteoarthritis (OA) is the leading musculoskeletal cause of disability. Despite this, there is no consensus on the precise definition of OA and what is the best treatment to improve symptoms and slow disease progression. Current pharmacological treatments include analgesics, non-steroidal anti-inflammatory drugs (NSAIDs) and cyclooxygenase (COX ...
Elena, Panova, Graeme, Jones
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