Author Information

Zhanglin Lin Cui
Wherly Hoffman

Abstract

Companion animals, commonly called pets, are animals such as dogs, cats, and horses. The companion animal drug market has expanded rapidly in recent years. Two major points of focus in companion animal drug development are therapeutics and parasiticides. From a statistics point of view, experimental design, experimental unit determination, sample size estimation and reestimation, treatment design, data transformation, multiple testing, and proper modeling are major statistical issues when efficacy evaluation in a companion animal study is conducted. These major statistical issues are addressed using two clinical studies as examples: Reconcile® (Fluoxetine) for the treatment of separation anxiety in dogs and Comfortis® (Spinosad) for the control of fleas in dogs.

Keywords

experimental design, experimental unit, sample size determination, data transformation, multiple testing, statistical model, companion animal

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Apr 27th, 11:30 AM

STATISTICAL ISSUES IN EFFICACY EVALUATION FOR COMPANION ANIMAL DRUG DEVELOPMENT

Companion animals, commonly called pets, are animals such as dogs, cats, and horses. The companion animal drug market has expanded rapidly in recent years. Two major points of focus in companion animal drug development are therapeutics and parasiticides. From a statistics point of view, experimental design, experimental unit determination, sample size estimation and reestimation, treatment design, data transformation, multiple testing, and proper modeling are major statistical issues when efficacy evaluation in a companion animal study is conducted. These major statistical issues are addressed using two clinical studies as examples: Reconcile® (Fluoxetine) for the treatment of separation anxiety in dogs and Comfortis® (Spinosad) for the control of fleas in dogs.