Core C: The focus of Core C, Biostatistics and Pharmacology, is to provide biostatistics and pharmacology support to all projects in the application. The Core is composed of two complementary components. The first is a biostatistics design and analysis support component. All projects have experiments that have elements of variability in results, requiring statistical input. In addition, this Core will provide pharmacologic support in particular to Projects 3 and 4 but also for the IPCP as a whole.
Specific aims are:
Specific Aim 1 : To provide expertise and assistance on study design and statistical analysis. 1. Aid in the statistical components of the design of the experiments in Projects 1 and 2. 2. Develop statistical analysis plans for Projects 3 and 4. 3. Perform statistical analyses, summarize results and participate in dissemination for all 4 projects.
Specific Aim 2 : To provide pharmacokinetics (PK) and pharmacodynamic (PD) support 1. Develop an allometric model to predicts human exposure based on historical and Project 3 data 2. Perform pharamcokinetic/pharmacodynamic modeling using population pharmacokinetics approaches for data from both Projects 3 and 4 3. Create a clinical trial simulation for the subsequent clinical study after Project 4 4. Aid in the selection of other NK-1R antagonists based on Projects 1, 2 and Core B experiments in contributing the relevant pharmacological information.
Specific Aim 3 : To provide information systems and data management support 1. Design and maintain a database to accommodate all 4 projects and Core B, with appropriate permissions to enter/review data and allowing access from four geographical sites 2. Upload data as necessary, manage and correct data 3. Implement a data sharing plan.
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