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Statistical Issues In Efficacy Evaluation For Companion Animal Drug Development, Zhanglin Lin Cui, Wherly Hoffman Apr 2008

Statistical Issues In Efficacy Evaluation For Companion Animal Drug Development, Zhanglin Lin Cui, Wherly Hoffman

Conference on Applied Statistics in Agriculture

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 …


Sample Size Determination In Animal Health Studies, Zhanglin Cui, Alan G. Zimmermann, Daniel H. Mowrey Apr 2007

Sample Size Determination In Animal Health Studies, Zhanglin Cui, Alan G. Zimmermann, Daniel H. Mowrey

Conference on Applied Statistics in Agriculture

Oftentimes in animal health studies, a treatment group is randomly assigned to a pen of animals, and the pen of animals as a whole is treated (fed the same medicated feed or water) together. In this scenario, the pen of animals is the experimental unit and the individual animal may be an observational unit. In addition to having the pen as the experimental unit, if multiple sites are used and site is treated as a random factor, this adds complexity to the study. To properly design the study, it is necessary to determine the number of animals in a pen, …