Pathology and Veterinary Support for Preclinical Toxicology Studies

临床前毒理学研究的病理学和兽医支持

• 批准号: 8737152
• 负责人: JOHN PLETCHER
• 金额: $ 5.32万
• 依托单位: CHARLES RIVER LABORATORIES INTNTL, INC.
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-30 至 2013-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8737152
• 关键词: Animals; Autopsy; Binding; Biological Markers; Clinical Trials; Contracts; Detection; Developmental Therapeutics Program; Diagnosis; Electron Microscopy; Ensure; Evaluation; Histologic; Histopathology; Immunohistochemistry; Laboratories; Lesion; Maintenance; Nomenclature; Paraffin Embedding; Pathologic; Pathologist; Pathology; Peer Review; Performance; Pharmaceutical Preparations; Pharmacology and Toxicology; Plastics; Preclinical Drug Development; Preparation; Procedures; Qualifying; Safety; Scheme; Slide; Specificity; Staining method; Stains; Support Contracts; Therapeutic antibodies; Tissues; Toxic effect; Toxicology; Veterinary Pathology; Work; cancer diagnosis; cancer therapy; drug candidate; drug development; human tissue; immunocytochemistry; meetings; operation; pre-clinical; programs; repository

The objective of this contract is to support the Developmental Therapeutics Program's (DTP) drug development effort and also perform critical activities for the Division of Cancer Treatment and Diagnosis (DCTD) in order to allow potential drug candidates proceed to clinical trials. Toxicology studies are conducted in intact, healthy, experimental animals as the final step in the preclinical drug development scheme. Histologic examination of lesions produced by the drug under evaluation is a crucial endpoint in the determination of a drug's safety and toxicity and in the reversibility of that toxicity. This contract supports the NCI in a variety of functions including, independent pathology assessment of toxicology studies (assures quality and consistency amongst the contract laboratories); histopathology support for studies as needed; repository storage of pathology materials and DTP documents; determination of tissue binding specificity of therapeutic antibodies; and performance of specialized histologic procedures such as immunohistochemistry.

这份合同的目的是支持开发治疗计划(DTP)的药物开发工作，并为癌症治疗和诊断部(DCTD)执行关键活动，以便使潜在的候选药物能够进入临床试验。毒理学研究是在完整、健康的实验动物身上进行的，作为临床前药物开发计划的最后一步。对正在评估的药物产生的损伤进行组织学检查是确定药物的安全性和毒性以及该毒性的可逆性的关键终点。 该合同在多种职能方面为NCI提供支持，包括毒理学研究的独立病理学评估(确保合同实验室之间的质量和一致性)；根据需要为研究提供组织病理学支持；病理材料和DTP文件的储存库；确定治疗性抗体的组织结合特异性；以及执行专门的组织学程序，如免疫组织化学。