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首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >An integrated clinical pharmacology approach for deriving dosing recommendations in a regulatory setting: Review of recent cases in psychiatry drugs
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An integrated clinical pharmacology approach for deriving dosing recommendations in a regulatory setting: Review of recent cases in psychiatry drugs

机译:一种综合的临床药理学方法,可在监管环境中得出用药建议:精神病药物近期病例回顾

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摘要

Clinical pharmacology as an interdisciplinary science is unique in its capacity and the diversity of the methods and approaches it can provide to derive dosing recommendations in various subpopulations. This article illustrates cases where an integrated clinical pharmacology approach was used to derive dosing recommendations for psychiatry drugs within regulatory settings. The integrated approach is based on the view that once a drug is shown to be effective in the general population, it is reasonable to take into consideration other relevant findings and the use of alternative scientific tools and analysis to derive dosing recommendations in specific populations. The method provides useful means to solve the challenges of the paucity of available data and lead to clear dosing instructions. This in turn expands the benefits of any given drug to all individuals in which the drug is likely to be effective.
机译:作为跨学科科学的临床药理学在其能力以及其可提供的方法和方法上的多样性是独特的,以提供各种亚人群的剂量推荐。本文说明了使用综合临床药理学方法得出在监管环境中精神病学药物的剂量建议的情况。综合方法是基于这样的观点,即一旦一种药物在一般人群中被证明是有效的,就应该考虑其他相关发现以及使用替代性科学工具和分析来得出特定人群的剂量建议是合理的。该方法提供了有用的手段来解决可用数据不足的挑战,并导致清晰的剂量说明。这继而将任何给定药物的益处扩展到该药物可能在其中有效的所有个体。

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