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

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

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 activ...

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Bibliographic Details
Main Authors: Laurynas Mockeliunas, Alan Faraj, Rob C. van Wijk, Caryn M. Upton, Gerben van den Hoogen, Andreas H. Diacon, Ulrika S. H. Simonsson
Format: Article
Language:English
Published: Frontiers Media S.A. 2023-04-01
Series:Frontiers in Pharmacology
Subjects:
tuberculosis
early bactericidal activity
sample size
pharmacometrics
model-based analysis
Online Access:https://www.frontiersin.org/articles/10.3389/fphar.2023.1150243/full

Internet

https://www.frontiersin.org/articles/10.3389/fphar.2023.1150243/full

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