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Core C – Drug Metabolism, Pharmacokinetics and Toxicology (DMPK/Tox)

Core C – Drug Metabolism, Pharmacokinetics and Toxicology (DMPK/Tox)
核心 C — 药物代谢、药代动力学和毒理学 (DMPK/Tox)
批准号:
10513938
负责人:
Alexander Kolykhalov
金额:
$811.65万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2022
资助国家:
美国
项目状态:
未结题
起止时间:
2022-05-16 至 2025-04-30

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项目成果

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中文摘要
翻译
摘要-核心C 核心C将为AC/DC核心和项目提供药物代谢、药代动力学和毒理学 (DMPK/Tox)数据,以指导电极导线优化、耐受性和药效学特征分析。核心 C带来了行业经验丰富的专业知识和药物开发的成功记录,例如 莫努匹拉韦的临床前表征(正在考虑紧急使用许可作为治疗 用于SARS-CoV-2感染)和EIDD-2173(目前处于B型肝炎病毒感染的2期临床试验中)。 因此,所有AC/DC DMPK/Tox操作都集中到核心C中,以实现协同效应 通过生成对多个项目至关重要且适用的数据,避免重复研究。的 确认的命中物和早期先导物的溶解性、稳定性、细胞摄取和细胞代谢特征将被 确定过滤具有低成功概率的那些并且通知迭代发现和优化。 将提供药物代谢、药代动力学和组织分布数据,为动物疗效研究提供信息 和铅优化。最后,将使用体外试验和非体外试验评估晚期导联的耐受性。 GLP剂量范围确定毒代动力学研究。
英文摘要
Summary – Core C Core C will provide AC/DC Cores and Projects with the drug metabolism, pharmacokinetic and toxicology (DMPK/Tox) data that is required to guide lead optimization, tolerability, and pharmacodynamic profiling. Core C brings industry seasoned expertise and a successful track record of drug development as exemplified by the preclinical characterization of molnupiravir (under consideration for Emergency Use Authorization as a treatment for SARS-CoV-2 infections), and EIDD-2173 (currently in Phase 2 clinical trials for hepatitis B virus infections). All AC/DC DMPK/Tox operations have accordingly been centralized into Core C to provide the synergies realized by generating data that is crucial and applicable to multiple projects, and to avoid redundant studies. The solubility, stability cellular uptake and cellular metabolic profiles of validated hits and early leads will be determined to filter those with a low probability of success and to inform iterative discovery and optimization. Drug metabolism, pharmacokinetic and tissue distribution data will be provided to inform animal efficacy studies and lead optimization. Finally, the tolerability of late leads will be assessed with both in vitro assays and non- GLP dose range finding toxicokinetic studies.
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