Power to identify exposure ‐response relationships in phase IIa pulmonary tuberculosis trials with multi‐dimensional bacterial load modeling
In conclusion, the power to identify an exposure-response relationship is low for TB drugs with moderate bactericidal activity or with a slow onset of activity. TTP provides the PK-PD model with more power to identify exposure-response relationships compared to CFU, and combined analysis or an unbalanced dosing group study design offers modest further improvement.
Source: CPT: Pharmacometrics and Systems Pharmacology - Category: Drugs & Pharmacology Authors: Simon E. Koele,
Thomas P. C. Dorlo,
Caryn M. Upton,
Rob E. Aarnoutse,
Elin M. Svensson Tags: ARTICLE Source Type: research