Dealing with Excess of Zeros in the Statistical Analysis of Magnetic Resonance Imaging Lesion Count in Multiple Sclerosis

Lesion count observed on brain magnetic resonance imaging scan is a common end point in phase 2 clinical trials evaluating therapeutic treatment in relapsing remitting multiple sclerosis (MS). This paper compares the performances of Poisson, zeroinflated poisson (ZIP), negative binomial (NB), and zero-inflated NB (ZINB) mixed-effects regression models in fitting lesion count data in a … Continued

Assessing the Efficiency of Mixed Effects Modeling in Quantifying Metabolism-based Drug-drug Interactions: Using In Vitro Data as an Aid to Assess Study Power

The clinical assessment of metabolic drug-drug interactions (mDDI) may involve population-based pharmacokinetic (POPPK) assessment as part of Phase 3 clinical trials. The elements of such POPPK study design have not been linked to prior information from in vitro experiments. Using in vitro-in vivo extrapolation techniques, implemented within Simcyp algorithms, the influence of POPPK study design … Continued

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