Janković Slobodan M, Mirković Nikola, Stojadinović Dobrivoje, Lukić Snežana
Faculty of Medical Sciences, University of Kragujevac, Kragujevac, Serbia.
Expert Opin Drug Metab Toxicol. 2025 Jul;21(7):801-810. doi: 10.1080/17425255.2025.2501128. Epub 2025 May 7.
Modelinformed precision dosing (MIPD) allows determining the optimal dosage regimen and its correction based on the target plasma/serum concentrations of the drug. MIPD software must go through a validation and clinical study of its effectiveness and safety before being used in clinical practice.
This narrative literature review provides insight into what is known to date about efficacy and safety trials of MIPD concept. Relevant publications were searched for in the PubMed database, without time or language constraints.
The application of MIPD in clinical practice logically and theoretically has great potential to improve the treatment of patients by leading to optimal exposure of target tissues to drugs, while achieving full effect and minimizing toxicity. Greater implementation of MIPD in clinical practice is hindered by the fact that the beneficial effects of MIPD on treatment outcomes and reduction of drug toxicity have been proven through clinical studies only for a small number of drugs. It is necessary to conduct well-designed clinical studies of the effects of MIPD, with sufficient statistical power, to prove the benefits of MIPD administration and to justify the costs of implementation in clinical practice.
模型指导的精准给药（MIPD）能够根据药物的目标血浆/血清浓度确定最佳给药方案及其校正方法。MIPD软件在临床实践中使用之前，必须经过有效性和安全性的验证及临床研究。
本叙述性文献综述深入探讨了目前已知的关于MIPD概念的有效性和安全性试验的情况。在PubMed数据库中检索了相关出版物，没有时间或语言限制。
MIPD在临床实践中的应用在逻辑和理论上具有巨大潜力，通过使靶组织达到最佳药物暴露水平，在实现充分疗效的同时将毒性降至最低，从而改善患者治疗效果。MIPD在临床实践中的更大规模应用受到阻碍，因为仅对少数药物通过临床研究证明了MIPD对治疗结果和降低药物毒性的有益作用。有必要进行精心设计的、具有足够统计学效力的MIPD效果临床研究，以证明MIPD给药的益处，并证明在临床实践中实施的成本合理。
