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    • 1. 发明申请
    • METHODS FOR CONDUCTING A CLINICAL TRIAL
    • 导致临床试验的方法
    • WO2009076227A2
    • 2009-06-18
    • PCT/US2008/085721
    • 2008-12-05
    • PAIN THERAPEUTICS, INC.FRIEDMANN, NadavBARBIER, Remi
    • FRIEDMANN, NadavBARBIER, Remi
    • G06Q50/00
    • G06Q50/22G06F19/00G16H10/20Y02A90/22Y02A90/26
    • The present disclosure relates generally to methods for selecting subjects for a clinical trial and includes methods for conducting a clinical trial to study the efficacy and/or safety of a drug by selecting subjects, for inclusion in a subsequent double-blind treatment period of the clinical trial, that do not exhibit adverse events to the drug. Methods for conducting a clinical trial may comprise the following: (1) an open-label titration period, (2) an adjustable dose treatment period and (3) a fixed dose treatment period. Optionally, the clinical trial may comprise a washout period prior to the open-label titration period. Also provided are methods for doing business by selecting subjects for a clinical trial for a drug that do not exhibit adverse events to the drug. Such methods may generate, revenue by reducing the length of time required to complete the clinical trial, increasing the likelihood that the drug will obtain regulatory approval and/or reducing the length of time it takes to bring advance the drug to market.
    • 本公开一般涉及用于选择临床试验的受试者的方法,并且包括用于进行临床试验以通过选择受试者来研究药物的功效和/或安全性的方法,以包括在临床的随后双盲治疗期 试验,不会对药物显示不良事件。 进行临床试验的方法可包括:(1)开放标签滴定期,(2)可调剂量治疗期和(3)固定剂量治疗期。 任选地,临床试验可以包括在开放标签滴定期之前的清除期。 还提供了通过选择不对药物显示不良事件的药物的临床试验的对象进行生意的方法。 这种方法可以通过减少完成临床试验所需的时间来增加收入,增加药物获得监管批准和/或减少将药物推向市场所需的时间长度的可能性。