使用可视化来计划利益风险评估
Michael W Colopy1, Lovemore Gakava2, Chen Chen3
1Statistical Sciences & Innovation, UCB Biosciences, Inc, 4000 Paramount Parkway Suite 200, Morrisville, NC, 27560, USA. michael.colopy@ucb.com.
Therapeutic innovation & regulatory science
|September 8, 2023
概括
利益风险评估计划 (BRAP) 积极概述药物开发评估,以确保利益超过风险. 本文详细介绍了一个假设的BRAP示例,指导研究药物的早期规划.
科学领域:
- 药物开发 药物开发
- 监管科学是一种监管科学.
- 临床试验规划 临床试验规划
背景情况:
- 利益风险评估计划 (BRAP) 对于评估试验药物至关重要.
- 建议在BRAP方面采取主动计划,而不是采取临时方法.
- 关于构建主动BRAP的有限的出版指南.
研究的目的:
- 为了说明积极的利益风险评估计划 (BRAP) 的结构和内容.
- 在药物开发生命周期中提供BRAP的假设示例.
- 突出BRAP过程中早期评估的重要性.
主要方法:
- 开发一个假设的药物开发场景.
- 在监管框架内对一系列计划评估进行可视化.
- 医疗状况和当前治疗方法的早期评估的整合.
主要成果:
- 假设的BRAP整合了决策里程碑的时间表和预先规定的评估.
- 早期评估确定了研究药物的关键考虑因素.
- 该示例展示了对利益风险评估的结构化,主动的方法.
结论:
- 积极的BRAP开发对于药物开发中的高效和知情决策至关重要.
- 在BRAP中的早期评估对于识别主要的利益风险因素至关重要.
- 这篇文章提供了一个创建有效BRAP的实际框架.
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