Exploiting Pharmacokinetic/Pharmacodynamic Methods for Optimizing and Accelerating Drug Development of Innovative Anti‐Infectives

TL;DR

This paper discusses how PK/PD methods can speed up drug development for new anti-infective treatments while reducing risks.

Contribution

The paper introduces novel PK/PD approaches for nontraditional anti-infectives like proteolysis-targeting chimeras.

Findings

PK/PD methods can optimize preclinical development of anti-infectives.

Nontraditional treatments pose new PK/PD challenges requiring innovative solutions.

Abstract

Bearing the increase in antimicrobial resistance as well as the emergence of novel viruses with pandemic potential in mind, it is obvious that development pathways need to be accelerated further. At the same time, attrition risks need to be minimized to allow that drugs reach the patient. For successful translation of novel anti‐infectives, several obstacles have to be overcome. This article illustrates recent developments and advances on pharmacokinetic (PK)/pharmacodynamic (PD) methods that can be employed to optimize preclinical development. It specifically emphasizes PK/PD considerations not only for classical antibacterials and antivirals but also for novel approaches, such as proteolysis‐targeting chimers, click‐to‐release systems, or anti‐virulence concepts. Particularly, the latter, nontraditional anti‐infective solutions pose novel challenges for PK/PD, as development pathways are not yet straightforward. Thus, this article also aims to provide ideas on how to tackle challenging PK/PD aspects of nontraditional anti‐infectives, taking advantage and inspiration from traditional development pathways.

This article focuses on the interplay of absorbed, distributed, metabolized, and excreted (ADME) properties; in vivo pharmacokinetics (PK); and pharmacodynamics (PD) supported by in silico PK/PD modeling techniques to improve drug development by acceleration of processes and reducing attrition risks. It provides insights on standard workflows and ways for development of novel treatment approaches such as proteolysis‐targeting chimer.© 2026 WILEY‐VCH GmbH

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