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MOLECULAR IMAGING IN DRUG DISCOVERY AND DEVELOPMENT

机译:药物发现与开发中的分子成像

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摘要

Non-invasive imaging has played an increasing role in the process of cardiovascular drug development. This review focuses specifically on the use of molecular imaging which has been increasing applied to improve and accelerate certain pre-clinical steps in drug development including the identification of appropriate therapeutic targets, evaluation of on-target and off-target effects of candidate therapies, assessment of dose response, and the evaluation of drug or biologic biodistribution and pharmacodynamics. Unlike the case in cancer medicine, in cardiovascular medicine molecular imaging has not been used as a primary surrogate clinical endpoint for drug approval. However, molecular imaigng has been applied in early clinical trials, particularly in Phase 0 studies, to demonstrate “proof of concept” or to explain variation in treatment effect. Many of these applications where molecular imaging has been used in drug development have involved the “retasking” of technologies that were originally intended as clinical diagnostics. With greater experience and recognition of the rich information provided by in vivo molecular imaging, it is anticipated that it will increasingly be used to address the enormous time and costs associated with bringing a new drug to clinical launch.
机译:非侵入性成像在心血管药物开发过程中起着越来越重要的作用。这篇综述特别关注分子成像的使用,这种分子成像已被越来越多地用于改善和加速药物开发中的某些临床前步骤,包括确定合适的治疗靶标,评估候选疗法的靶标和靶标效果,评估剂量反应,药物或生物学生物分布和药效学的评估。与癌症医学不同,在心血管医学中,分子成像尚未被用作药物批准的主要替代临床终点。然而,伊马格分子已用于早期临床试验中,尤其是在0期研究中,以证明“概念验证”或解释治疗效果的差异。在药物开发中已使用分子成像的许多这些应用都涉及到了原本打算用于临床诊断的技术的“重新分配”。随着更多的经验和对体内分子成像提供的丰富信息的认识,人们预计它将越来越多地用于解决与将新药物投入临床相关的大量时间和成本。

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