Model-informed precision dosing: State of the art and future perspectives

IF 15.2 1区 医学 Q1 PHARMACOLOGY & PHARMACY Advanced drug delivery reviews Pub Date : 2024-08-17 DOI:10.1016/j.addr.2024.115421
I.K. Minichmayr , E. Dreesen , M. Centanni , Z. Wang , Y. Hoffert , L.E. Friberg , S.G. Wicha
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Abstract

Model-informed precision dosing (MIPD) stands as a significant development in personalized medicine to tailor drug dosing to individual patient characteristics. MIPD moves beyond traditional therapeutic drug monitoring (TDM) by integrating mathematical predictions of dosing, and considering patient-specific factors (patient characteristics, drug measurements) as well as different sources of variability. For this purpose, rigorous model qualification is required for the application of MIPD in patients. This review delves into new methods in model selection and validation, also highlighting the role of machine learning in improving MIPD, the utilization of biosensors for real-time monitoring, as well as the potential of models integrating biomarkers for efficacy or toxicity for precision dosing. The clinical evidence of TDM and MIPD is discussed for various medical fields including infection medicine, oncology, transplant medicine, and inflammatory bowel diseases, thereby underscoring the role of pharmacokinetics/pharmacodynamics and specific biomarkers. Further research, particularly randomized clinical trials, is warranted to corroborate the value of MIPD in enhancing patient outcomes and advancing personalized medicine.

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基于模型的精确配料:技术现状与未来展望。
模型信息精准给药(MIPD)是个性化医疗领域的一项重大发展,可根据患者的个体特征调整药物剂量。MIPD 超越了传统的治疗药物监测 (TDM),它整合了剂量的数学预测,并考虑了患者的特定因素(患者特征、药物测量)以及不同的变异性来源。为此,在患者中应用 MIPD 需要严格的模型鉴定。本综述深入探讨了模型选择和验证的新方法,还强调了机器学习在改进 MIPD 方面的作用、生物传感器在实时监测方面的应用,以及整合疗效或毒性生物标志物的模型在精准用药方面的潜力。讨论了 TDM 和 MIPD 在各个医学领域的临床证据,包括感染医学、肿瘤学、移植医学和炎症性肠病,从而强调了药代动力学/药效学和特定生物标记物的作用。有必要开展进一步的研究,特别是随机临床试验,以证实 MIPD 在提高患者疗效和推进个性化医疗方面的价值。
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来源期刊
CiteScore
28.10
自引率
5.00%
发文量
294
审稿时长
15.1 weeks
期刊介绍: The aim of the Journal is to provide a forum for the critical analysis of advanced drug and gene delivery systems and their applications in human and veterinary medicine. The Journal has a broad scope, covering the key issues for effective drug and gene delivery, from administration to site-specific delivery. In general, the Journal publishes review articles in a Theme Issue format. Each Theme Issue provides a comprehensive and critical examination of current and emerging research on the design and development of advanced drug and gene delivery systems and their application to experimental and clinical therapeutics. The goal is to illustrate the pivotal role of a multidisciplinary approach to modern drug delivery, encompassing the application of sound biological and physicochemical principles to the engineering of drug delivery systems to meet the therapeutic need at hand. Importantly the Editorial Team of ADDR asks that the authors effectively window the extensive volume of literature, pick the important contributions and explain their importance, produce a forward looking identification of the challenges facing the field and produce a Conclusions section with expert recommendations to address the issues.
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