Pivotal Role of Translation in Anti‐Infective Development

The value of model-based translation in drug discovery and development is now effectively being recognized many disease areas among various stakeholders. Such quantitative approaches are expected to facilitate the selection on which compound prioritize for successful development, predict human efficacious dose based preclinical data with adequate precision, guide design, de-risk later stages. importance time-dependencies, typically species-dependent due different turnover rates biological processes, is, however, often neglected. For bacterial infections, choice dosing regimen relying pharmacokinetic (PK) pharmacodynamic (PD) data, because load severity, consequently PK/PD relationship, cannot be quantified well clinical given low-information end points used. It time recognize limitations using time-collapsed (i.e., methods where targets summary measures exposure response). Models describing full time-course captures important information distribution, growth, antibiotic killing, resistance can account species-differences PK profiles driving killing. Furthermore, a approach translation, we take holistic joint model vitro, vivo, as incorporating contribution immune system. advancements anticipated rational decision making during stages optimization treatment regimens groups patients.