CORE--Biostatistics and Pharmacology

核心--生物统计学和药理学

基本信息

批准号：
7516471
负责人：
AVITAL CNAAN
金额：
$ 24.44万
依托单位：
CHILDREN'S HOSP OF PHILADELPHIA
依托单位国家：
美国
项目类别：
财政年份：
2007
资助国家：
美国
起止时间：
2007-08-01 至 2009-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7516471
关键词：
Adult Biometry Biostatistics Core Canis familiaris Choices and Control Clinical Research Clinical Trials Clinical Trials Design Collaborations Data Data Collection Databases Decision Making Documentation Dose Drug Kinetics Elements Experimental Designs Ferrets HIV Human Information Systems Intranet Investigational Drugs Laboratories Lead Literature Macaca mulatta Manuscripts Measures Modeling Outcome Outcome Study Patients Pharmacodynamics Pharmacology Policies Population Process Range Rattus Reporting Research Design Research Personnel Resources SIV Safety Sample Size Screening procedure Secure Site Staging Statistical Methods Substance P Receptor Summary Reports System Therapeutic United States National Institutes of Health Viral Load result abstracting aprepitant base data management design exposed human population human data isopentenyl methylenediphosphonate pharmacodynamic model pre-clinical programs research study response simulation symposium

项目摘要

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.

核心C：核心C，生物统计学和药理学，重点是为申请中的所有项目提供生物统计学和药理学支持。核心由两个互补的组件组成。第一个是生物统计设计和分析支持组件。所有项目的实验都具有结果可变性，需要统计输入。此外，该核心将为项目 3 和 4 以及整个 IPCP 提供药理学支持。具体目标是：具体目标 1：提供研究设计和统计分析方面的专业知识和帮助。 1. 协助项目 1 和 2 中实验设计的统计部分。 2. 制定项目3和4的统计分析计划。 3. 对所有4个项目进行统计分析、总结结果并参与传播。具体目标 2：提供药代动力学 (PK) 和药效学 (PD) 支持 1. 开发异速生长模型，根据历史数据和项目 3 数据预测人类暴露情况 2. 使用群体药代动力学方法对项目 3 和 4 的数据进行药代动力学/药效建模 3. 为项目4之后的后续临床研究创建临床试验模拟 4. 根据项目1、2和核心B实验帮助选择其他NK-1R拮抗剂，提供相关药理学信息。具体目标3：提供信息系统和数据管理支持 1. 设计和维护一个数据库，以容纳所有 4 个项目和核心 B，具有输入/审查数据的适当权限，并允许从四个地理位置进行访问 2. 根据需要上传数据，管理和更正数据 3. 实施数据共享计划。