Abstract
PD0332334 (PD334) is a novel beta amino acid analog of pregabalin (Pgb). Pregabalin has been previously studied in six clinical studies of general anxiety disorder (GAD). Because these compounds have similar pharmacology, certain features of their dose response relationships could be similar. Thus, data from the pregabalin GAD program was used to provide information about the safety (incidence of somnolence) and efficacy (reduction in Hamilton Anxiety Rating score) dose–response relationships for PD334 in GAD. This chapter illustrates the use of prior pregabalin data from other large-scale clinical studies to select the PD334 dose range to study in Phase 3, and the implementation of models based on assumptions of common PD334/pregabalin dose–response features that resulted from consideration of the comparative pharmacology. External validation of the PD334 dose–response model with Phase 3 data is demonstrated.
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Lockwood, P.A., Mandema, J.W. (2011). Model Based Development of an Agent for the Treatment of Generalized Anxiety Disorder. In: Kimko, H., Peck, C. (eds) Clinical Trial Simulations. AAPS Advances in the Pharmaceutical Sciences Series, vol 1. Springer, New York, NY. https://doi.org/10.1007/978-1-4419-7415-0_15
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DOI: https://doi.org/10.1007/978-1-4419-7415-0_15
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