Article
Derivation of Phase 3 dosing for peginterferon lambda-1a in chronic hepatitis C, Part 1: Modeling optimal treatment duration and sustained virologic response rates.
Journal of clinical pharmacology - 1 Jan 2015
Wang Xiaodong, Hruska Matthew, Chan Phyllis, Ahmad Alaa, Freeman Jeremy, Horga Maria Arantxa, Hillson Jan, Kansra Vikram, Lopez-Talavera Juan-Carlos
Abstract excerpt
Peginterferon lambda-1a (Lambda) is under clinical development for the treatment of chronic hepatitis B and C virus (HBV, HCV, respectively) infection. This is the first of two manuscripts detailing the pharmacodynamic derivation of Lambda dosing and treatment durations for Phase 3 studies in HCV, based on Phase 2 data. We describe here the derivation of a population model of Lambda exposure; the adaptation of a...
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