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

• Autors principals: Laurynas Mockeliunas (Autor), Alan Faraj (Autor), Rob C. van Wijk (Autor), Caryn M. Upton (Autor), Gerben van den Hoogen (Autor), Andreas H. Diacon (Autor), Ulrika S. H. Simonsson (Autor)
• Format: Llibre
• Publicat: Frontiers Media S.A., 2023-04-01T00:00:00Z.
• Matèries: article
• Accés en línia: 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...