Standards for model-based early bactericidal activity analysis and sample size determination in tuberculosis drug development.

ABSTRACT: Background: A critical step in tuberculosis (TB) drug development is the Phase 2a early bactericidal activity (EBA) study which informs if a new drug or treatment has short-term activity in humans. The aim of this work was to present a standardized pharmacometric model-based early bactericidal activity analysis workflow and determine sample sizes needed to detect early bactericidal activity or a difference between treatment arms. Methods: Seven different steps were identified and developed for a standardized pharmacometric model-based early bactericidal activity analysis approach. Non-linear mixed effects modeling was applied and different scenarios were explored for the sample size calculations. The sample sizes needed to detect early bactericidal activity given different TT

SUBMITTER: Mockeliunas L 

PROVIDER: S-EPMC10133723 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature