Statistical Support for NTP and NIEHS

该合同的目标是提供统计、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和NTP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(DIR)进行的实验室和方法学调查。为了支持NTP为期两年的生物检测，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。该软件包括用于对肿瘤发病率、非肿瘤性病变发病率、体重、存活率、食物和水消耗量进行统计分析的程序，以及用于生成随时可用相机绘制的体重和存活率估计图的程序。为了支持NTP毒理学研究，Constella提供毒性终点的剂量-反应分析，供NTP技术报告使用。毒性终点包括器官和体重、存活、临床化学、血液学和组织病理学观察。康斯特拉还对NTP连续繁育项目的生殖评估数据进行统计分析。这些分析包括生育能力、精子形态、阴道细胞学和窝窝数据的测量。康斯特拉还对选定的化学品进行毒物动力学建模。这些模型超越了统计分析，因为它们可以用来进行基于生理学的预测。作为对NTP支持的一部分，Constella负责维护对照动物两年生物检测中肿瘤发病率的历史控制数据库，并负责短期毒性和生殖研究的毒性终点。Constella每年汇总肿瘤发病率数据库，并将结果以电子和硬拷贝格式提供给NTP。应NTP科学家的要求，毒性和生殖数据库不断更新和汇总。根据NTP机构间替代毒理学方法评估中心(NICEATM)的要求，Constella进行统计分析，以验证被认为是现有动物试验的替代试验。为支持内部研究司(DIR)，康斯特拉提供统计咨询专业知识、实验数据分析、对人体研究的统计支持，以及对实验和方法学研究的计算支持。Constella与NIEHS的科学家合作，通过协助实验室实验的设计和解释、提供统计计算以及汇总和展示实验数据以供同行评议的出版物，为实验室研究提供统计支持。Constella还支持对DIR重要的方法论研究，通过计算机模拟研究替代统计过程的性质，并为生物数学研究工作提供理论和计算支持。

The objectives of this contract are to provide statistical, biomathematical, and computational expertise and resources to summarize, analyze, and aid in the interpretation of data from various NIEHS and NTP 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 control 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.