CORE--Biostatistics and Pharmacology

核心--生物统计学和药理学

• 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
• 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

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的重点是为应用程序中的所有项目提供生物统计学和药理学支持。核心由两个互补成分组成。第一个是生物统计学设计和分析支持部分。所有项目的实验都具有结果可变性的元素，需要统计输入。此外，该核心将为3和4项目提供药理支持，但也将为整个IPCP提供。具体目的是： 特定目的1：为研究设计和统计分析提供专业知识和帮助。 1。辅助项目1和2中实验设计的统计组成部分。 2。制定项目3和4的统计分析计划。 3.执行统计分析，总结结果并参与所有4个项目的传播。 特定目的2：提供药代动力学（PK）和药效学（PD）支持 1。开发一个异形模型，以根据历史和项目3数据来预测人类接触 2。使用种群药代动力学方法进行研究3和4 3。为项目4之后的后续临床研究创建临床试验模拟 4。基于项目1、2和核心B实验的其他NK-1R拮抗剂的帮助，以贡献相关的药理学信息。 特定目标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，以适应所有4个项目和核心B，并具有适当的输入/审查数据的权限，并允许从四个地理网站访问 2。根据需要上传数据，管理和纠正数据 3。实施数据共享计划。