The importance of pharmacokinetics and pharmacodynamics in antimicrobial drug development and their influence on the success of agents developed to combat resistant gram negative pathogens: A review.

Abstract

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.