Article
Derivation of Phase 3 dosing for peginterferon lambda-1a in chronic hepatitis C, Part 2: Exposure-response analyses for efficacy and safety variables.
Journal of clinical pharmacology - 1 Jan 2015
Hruska Matthew, Wang Xiaodong, Chan Phyllis, Ahmad Alaa, Freeman Jeremy, Horga Maria Arantxa, Hillson Jan, Kansra Vikram, Lopez-Talavera Juan-Carlos
Abstract excerpt
This is the second of two manuscripts detailing the pharmacodynamic derivation of peginterferon lambda-1a (Lambda) dosing and treatment durations for Phase 3 studies in hepatitis C virus (HCV) infection, based on Phase 2 data. Herein, we describe the derivation of regression models for 12-week on-treatment virologic response and safety outcomes at 120, 180, and 240 μg Lambda with ribavirin. In patients with HCV...
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