# Antimicrobial Pharmacokinetic and Pharmacodynamic Considerations in Special Populations: A Call to Action

## TL;DR

This paper emphasizes the need to improve antimicrobial dosing in special patient groups by addressing pharmacokinetic and pharmacodynamic variability.

## Contribution

The paper calls for inclusive clinical trials and precision dosing to address underrepresented PK/PD data in special populations.

## Key findings

- Special populations often face suboptimal antimicrobial dosing due to PK/PD variability.
- Current data gaps hinder effective treatment in patients with conditions like obesity and renal dysfunction.
- Improved modeling and real-world data collection are needed to enhance treatment outcomes.

## Abstract

Pharmacokinetic (PK) and pharmacodynamic (PD) variability in special populations can impact antimicrobial efficacy and safety. This review highlights the importance of PK/PD optimization in patients known to have altered PK, including those with obesity, cystic fibrosis, renal dysfunction, critical illness, transplantation, pregnancy, and/or significant burns. Historically, PK/PD data are underrepresented in these populations, leading to suboptimal dosing recommendations and increased risks of therapeutic failure or toxicity. Herein, we discuss key physiological alterations affecting antimicrobial PK/PD, regulatory challenges, and currently available solutions. To bridge these knowledge gaps, we advocate for broader patient inclusion in clinical trials, improved PK modeling, real-world data collection, and increased investment in precision dosing strategies. Addressing these issues has the potential to enhance patient outcomes, reduce antimicrobial resistance, and improve infectious diseases management. This review serves as a call to action for researchers, clinicians, and policymakers to prioritize PK/PD research in special patient populations.

This review highlights the need to optimize antimicrobial pharmacokinetics and pharmacodynamics in special populations, including those with critical illness, renal impairment, obesity, and cystic fibrosis. A call is made for inclusive clinical trial designs, enhanced therapeutic drug monitoring, precision dosing strategies, and policy-driven incentives to address current data gaps and improve clinical outcomes.