Power to identify exposure‐response relationships in phase IIa pulmonary tuberculosis trials with multi‐dimensional bacterial load modeling
Simon E. Koele,
Thomas P. C. Dorlo,
Caryn M. Upton
et al.
Abstract:Adequate power to identify an exposure‐response relationship in a phase IIa clinical trial for pulmonary tuberculosis (TB) is important for dose selection and design of follow‐up studies. Currently, it is not known what response marker provides the pharmacokinetic‐pharmacodynamic (PK‐PD) model more power to identify an exposure‐response relationship. We simulated colony‐forming units (CFU) and time‐to‐positivity (TTP) measurements for four hypothetical drugs with different activity profiles for 14 days. The po… Show more
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