Rodríguez-Gascón Alicia, Solinís María Ángeles, Isla Arantxa
Pharmacokinetic, Nanotechnology and Gene Therapy Group (PharmaNanoGene), Centro de investigación Lascaray ikergunea, Faculty of Pharmacy, University of the Basque Country UPV/EHU, Paseo de la Universidad 7, 01006 Vitoria-Gasteiz, Spain.
Bioaraba, Pharmacokinetic, Nanotechnology and Gene Therapy Group (PharmaNanoGene), 01006 Vitoria-Gasteiz, Spain.
Pharmaceutics. 2021 Jun 3;13(6):833. doi: 10.3390/pharmaceutics13060833.
Pharmacokinetic/pharmacodynamic (PK/PD) analysis has proved to be very useful to establish rational dosage regimens of antimicrobial agents in human and veterinary medicine. Actually, PK/PD studies are included in the European Medicines Agency (EMA) guidelines for the evaluation of medicinal products. The PK/PD approach implies the use of in vitro, ex vivo, and in vivo models, as well as mathematical models to describe the relationship between the kinetics and the dynamic to determine the optimal dosing regimens of antimicrobials, but also to establish susceptibility breakpoints, and prevention of resistance. The final goal is to optimize therapy in order to maximize efficacy and minimize side effects and emergence of resistance. In this review, we revise the PK/PD principles and the models to investigate the relationship between the PK and the PD of antibiotics. Additionally, we highlight the outstanding role of the PK/PD analysis at different levels, from the development and evaluation of new antibiotics to the optimization of the dosage regimens of currently available drugs, both for human and animal use.
药代动力学/药效学（PK/PD）分析已被证明在确定人用和兽用抗菌药物的合理给药方案方面非常有用。实际上，PK/PD研究已被纳入欧洲药品管理局（EMA）的药品评估指南。PK/PD方法意味着使用体外、离体和体内模型以及数学模型来描述动力学和动态学之间的关系，以确定抗菌药物的最佳给药方案，同时也用于确定敏感性断点和预防耐药性。最终目标是优化治疗，以实现疗效最大化、副作用最小化以及耐药性的出现最少化。在本综述中，我们回顾了PK/PD原理和模型，以研究抗生素的PK和PD之间的关系。此外，我们强调了PK/PD分析在不同层面的突出作用，从新抗生素的研发和评估到优化目前人用和兽用现有药物的给药方案。
