公开(公告)号：US20080075774A1

公开(公告)日：2008-03-27

申请号：US11834848

申请日：2007-08-07

Applicant: Robert WILLIAMS ,  Peter SILVERSTONE

Inventor： Robert WILLIAMS ,  Peter SILVERSTONE

IPC: A61K31/135 ,  A61K33/14 ,  A61K9/24 ,  A61K9/28 ,  A61P25/08

CPC classification number: A61K31/135 ,  A61K9/2846 ,  A61K9/2866 ,  A61K9/2886 ,  A61K33/00 ,  A61K2300/00

Abstract: Bupropion hydrobromide formulations as well as their use for the treatment of conditions is described.

公开(公告)号：US20060129326A1

公开(公告)日：2006-06-15

申请号：US11009578

申请日：2004-12-10

Applicant: Paul Braconnier ,  Peter Silverstone

Inventor： Paul Braconnier ,  Peter Silverstone

IPC: G06F19/00 ,  G06Q10/00 ,  G06Q50/00

CPC classification number: G06Q50/22 ,  G16H10/20

Abstract: The present invention provides a method, apparatus, and computer instructions for improved control of clinical trials. In a preferred embodiment, after a clinical trial is initiated, data is regularly cleaned and processed to statistically analyze the data. The outcome includes a predictive measure of the timing and level by which the study will achieve one or more statistically significant levels, allowing mid-course modifications to the study (e.g., in population size, termination, etc.). Modification can be planned as part of the initial protocol, using thresholds or other appropriate criteria relating to the statistical outcome, making possible pre-approved protocol changes based on the statistical findings. This process has significant implications for the management of clinical studies, including ensuring the minimum possible time and number of patients are used in clinical studies to either prove (or disprove) the clinical efficacy of drugs or treatments.

Abstract translation: 本发明提供了用于改善临床试验的控制的方法，装置和计算机指令。 在优选实施例中，在临床试验开始之后，定期清洁和处理数据以统计分析数据。 结果包括对研究将达到一个或多个统计学显着水平的时间和水平的预测性测量，允许对研究进行中期修改（例如，在群体大小，终止等）。 可以将修改计划作为初始协议的一部分，使用与统计结果相关的阈值或其他适当标准，从而根据统计结果使预先批准的协议变更成为可能。 这一过程对临床研究的管理具有重要意义，包括确保临床研究中使用最少可能的时间和数量的患者证明（或反驳）药物或治疗的临床疗效。