Palmer Mary E, Andrews Lauren J, Abbey Taylor C, Dahlquist Ashley E, Wenzler Eric
College of Pharmacy, University of Illinois Chicago, Chicago, IL, United States.
Front Pharmacol. 2022 Jul 25;13:888079. doi: 10.3389/fphar.2022.888079. eCollection 2022.
A deep understanding of an antimicrobial's critical pharmacokinetic and pharmacodynamic properties is crucial towards optimizing its use in patients and bolstering the drug development program. With the growing threat of antimicrobial resistance and decline in antimicrobial development, the advancement of complex and rigorous pharmacokinetic and pharmacodynamic studies over a short time span has renewed confidence in the value of pharmacokinetic and pharmacodynamic studies and allowed it to become fundamental component of a robust drug development program with high chances of successful approval. In addition, recent guidance by various regulatory bodies have reinforced that a strong and dedicated focus on pharmacokinetics and pharmacodynamics throughout research and development lead to the use of an optimized dosing regimen in Phase 3 trials, improving the probability of drug approval. The objective of this review is to demonstrate the importance of pharmacokinetic and pharmacodynamic studies in the drug development decision-making process by highlighting the developments in pharmacokinetic and pharmacodynamic methods and discuss the role of pharmacokinetic and pharmacodynamic studies in antimicrobial successes and failures.
深入了解抗菌药物的关键药代动力学和药效学特性对于优化其在患者中的使用以及加强药物研发计划至关重要。随着抗菌药物耐药性威胁的不断增加以及抗菌药物研发的减少，在短时间内推进复杂而严格的药代动力学和药效学研究重新唤起了人们对药代动力学和药效学研究价值的信心，并使其成为具有高获批成功率的稳健药物研发计划的基本组成部分。此外，各监管机构最近发布的指南强化了在整个研发过程中对药代动力学和药效学的高度专注会导致在3期试验中使用优化的给药方案，从而提高药物获批的概率。本综述的目的是通过突出药代动力学和药效学方法的进展来证明药代动力学和药效学研究在药物研发决策过程中的重要性，并讨论药代动力学和药效学研究在抗菌药物成败中的作用。
