Preclinical Toxicology & Pharmacology of Drugs Developed for Cancer

该合同的目的是获得治疗癌症和其他疾病(包括孤儿疾病)的新药候选的药理学和毒理学数据。具有诊断和监测肿瘤进展潜力的癌症显像剂也使用该合同进行评估。这些数据通常作为I期临床试验的研究新药(IND)申请的一部分提交给FDA，因此将符合FDA的所有指南。本合同的工作范围包括： A)验证用于剂量浓度分析和测定生物体液中候选药物浓度的分析程序。 B)在啮齿动物和非啮齿动物物种中进行药代动力学研究，以确定血浆消除动力学。确定非肠外途径的生物利用度和血浆清除率，以确定在血浆中产生有效浓度所需的剂量，并将这些信息应用于设计针对候选药物的毒理学研究。 C)进行初步毒理学研究，以确定候选药物在啮齿动物和非啮齿动物物种中的相对毒性和潜在的剂量限制毒性。

The objective of this contract is to acquire pharmacologic and toxicologic data on new drug candidates for the treatment of cancer and other diseases, including orphan diseases. Cancer imaging agents with the potential for diagnosing and monitoring tumor progression are evaluated using this contract as well. These data are routinely submitted to the FDA as part of an investigational new drug (IND) application for a Phase I clinical trial, and as such will conform with all FDA Guidances. The work scope for this contract includes: a) Validation of analytical procedures for dose concentration analyses and for assaying drug candidate concentrations in biological fluids. b) Conduct pharmacokinetic studies in rodent and non-rodent species to determine plasma elimination kinetics. Determine bioavailability of non-parenteral routes and plasma clearance rates in order to establish the dose required to produce effective concentrations in plasma and apply the information to design drug candidate-specific toxicology studies. c) Conduct preliminary toxicology studies to establish relative toxicity of the drug candidate in rodent and non-rodent species and potential dose limiting toxicities.