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Systems and methods for improved assessment and reporting of the efficacy and safety of drug, biologic, botanical, vitamin, medical food and medical device treatments

机译:用于改进对药物,生物,植物,维生素,医疗食品和医疗器械治疗的功效和安全性的评估和报告的系统和方法

摘要

A system and method are described to identify risks and assess the efficacy and safety associated with drug, biologic, nutritional, medical food and medical device therapies throughout the treatment development process. The data measured are evaluated in relation to a patient's specific physiologic state (for example, data collected throughout a biological cycle) to determine the attribution to specific organ systems, functions or mechanisms, and are reported within this context. Further, the system and method enable real time access and entry of patient data stored in a centralized database via the internet or other computing device.
机译:描述了一种系统和方法,以识别风险并评估在整个治疗开发过程中与药物,生物学,营养,医疗食品和医疗器械疗法相关的功效和安全性。针对患者的特定生理状态评估测量的数据(例如,在整个生物周期中收集的数据),以确定对特定器官系统,功能或机制的归属,并在此情况下进行报告。此外,该系统和方法使得能够经由互联网或其他计算设备实时访问和输入存储在集中式数据库中的患者数据。

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