NTP statistical and computer support

该合同的目的是为国家毒理学计划（NTP）的危害评估活动提供支持，这些活动旨在预防因环境暴露于化学或物理制剂而引起的疾病或不良影响。该合同提供统计，生物数学和计算专业知识和资源，以总结，分析和帮助解释来自各种NIEHS实验研究的数据。这些研究包括由国家毒理学计划（NTP）进行的致癌生物测定和毒理学研究，以及由校内研究部（Division of Intramural Research）进行的实验室和方法学研究。为了支持NTP的两年生物测定，Constella负责开发、维护和升级毒理学数据管理系统（TDMS）的统计软件。该软件包括用于肿瘤发病率、非肿瘤性病变发病率、体重、存活率、食物和水消耗的统计分析程序，以及用于生成体重和存活率估计的相机就绪图的程序。为了支持NTP毒理学研究，Constella提供毒性终点的剂量反应分析，用于NTP技术报告。毒性终点包括器官和体重、存活率、临床化学、血液学和组织病理学观察结果。Constella还对NTP通过连续育种计划进行的生殖评估的数据进行了统计分析。这些分析涉及生育力、精子形态、阴道细胞学和窝仔数据的测量。Constella还对选定的化学品进行毒代动力学建模。这些模型超越了统计分析，因为它们可以用于进行基于生理学的预测。作为NTP支持的一部分，Constella负责维护对照动物两年生物测定中肿瘤发生率的历史数据库，以及短期毒性和生殖研究中的毒性终点。Constella每年总结肿瘤发病率数据库，并以电子和硬拷贝格式向NTP提供结果。毒性和生殖数据库不断更新，并应NTP科学家的要求进行总结。根据NTP替代毒理学方法评价机构间中心（NICEATM）的要求，Constella进行了统计分析，以验证被视为替代现有动物试验的替代试验。为了支持校内研究部，constella提供统计咨询专业知识，实验数据分析，人类研究的统计支持，以及实验和方法研究的计算支持。与NIEHS科学家合作，Constella通过帮助实验室实验的设计和解释，提供统计计算以及总结和显示同行评审出版物的实验数据，为实验室研究提供统计支持。Constella还支持方法学研究的重要性，通过计算机模拟和生物数学研究工作提供理论和计算支持，调查替代统计程序的属性。 关键词NTP; TDMS;生物统计学;甲骨文公司;数据分析;生物统计学;实验设计;统计计算;（美国）国家毒理学计划;毒代动力学模型;癌症生物测定;生殖;生物数学建模;生物信息学

The goal of this contract is to provide support of National Toxicology Program (NTP) hazard assessment activities targeted toward the prevention of diseases or adverse effects caused by environmental exposure to chemical or physical agents. This contract provides statistical, biomathematical, and computational expertise and resources to summarize, analyze, and aid in the interpretation of data from various NIEHS experimental studies. These studies consist of carcinogenesis bioassays and toxicology studies carried out by the National Toxicology Program (NTP), and laboratory and methodological investigations carried out by the Division of Intramural Research (DIR). In support of the NTP's two-year bioassays, Constella has responsibility for developing, maintaining, and upgrading statistical software for the Toxicology Data Management System (TDMS). This software includes programs for statistical analysis of tumor incidence, non-neoplastic lesion incidence, body weight, survival, food and water consumption, and programs for producing camera ready plots of body weight and survival estimates. In support of NTP toxicology studies, Constella provides dose-response analyses of toxicity endpoints for use in NTP Technical Reports. Toxicity endpoints include organ and body weights, survival, clinical chemistry, hematology, and histopathology observations. Constella also conducts statistical analyses of data from NTP's Reproductive Assessment by Continuous Breeding Program. These analyses involve measurements of fertility, sperm morphology, vaginal cytology, and litter data. Constella also conducts toxicokinetic modeling of selected chemicals. These models go beyond the statistical analysis in that they can be used to make physiology based predictions. As part of its support of NTP, Constella is responsible for maintaining historical databases for tumor incidence in control animals from two-year bioassays and for toxicity endpoints from short-term toxicity and reproductive studies. Constella summarizes the tumor incidence database annually and makes the results available to NTP in electronic and hardcopy formats. Toxicity and reproductive databases are updated continuously and summarized at the request of NTP scientists. Constella conducts statistical analyses for validating alternative tests being considered as replacements for existing animal tests, as requested by the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM). In support of the Division of Intramural Research (DIR), Constella provides statistical consulting expertise, analysis of experimental data, statistical support for human studies, and computational support for experimental and methodological research. In collaboration with NIEHS scientists, Constella provides statistical support for laboratory research by aiding in the design and interpretation of laboratory experiments, by providing statistical computations, and by summarizing and displaying experimental data for peer-reviewed publication. Constella also supports methodological research of importance to DIR by investigating properties of alternative statistical procedures by computer simulation and by supplying theoretical and computational support for biomathematical research efforts. Keywords NTP;TDMS;biometrics;Oracle;Data analysis; biostatistics; experimental design; statistical computing; National Toxicology Program; toxicokinetic models; cancer bioassays; reproduction; biomathematical modeling; bioinformatics.