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

• Main Authors: Laurynas Mockeliunas (Author), Alan Faraj (Author), Rob C. van Wijk (Author), Caryn M. Upton (Author), Gerben van den Hoogen (Author), Andreas H. Diacon (Author), Ulrika S. H. Simonsson (Author)
• Format: Book
• Published: Frontiers Media S.A., 2023-04-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

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...