PHARMACCEUTICS FORMULATION/CHEMISTRY MANUFACTURING AND CONTROLS CONSULTING SERVICES FOR SMALL MOLECULES AND/OR BIOLOGICS

小分子和/或生物制剂的药物制剂/化学制造和控制咨询服务

• 批准号: 10721140
• 负责人: NACHIMUTHU SOUNDARARAJAN
• 金额: $ 0.62万
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-02 至 2023-09-01
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10721140
• 关键词: Biological Products; Chemicals; Chemistry; Clinical Research; Conduct Clinical Trials; Consult; Contracts; Development; Dose; Drug Kinetics; Electronic Mail; Ensure; European; Experimental Designs; Feedback; Formulation; Guidelines; Human; International; Investigational Drugs; Lead; Marketing; Medicine; Methodology; Pharmaceutical Preparations; Pharmacologic Substance; Pharmacy (field); Preparation; Process; Recommendation; Reporting; Research Contracts; Risk; Role; Science; Services; Teleconferences; Telephone; Time; United States National Institutes of Health; Visit; analytical method; assay development; authority; design; drug metabolism; lead optimization; member; method development; product development; programs; small molecule

Pharmaceutics / Formulation / CMC Pharmaceutics / Formulation/ CMC consultants will be expected to provide executive (senior scientific)-level Pharmaceutics / Formulation/ CMC expertise and contribute feedback and guidance on projects to the NIH and to LDT members through video/teleconference calls and by email. The role of the Pharmaceutics / Formulation/CMC consultant may include but is not limited to the following responsibilities and tasks: 1. Evaluate Pharmaceutics / Formulation / CMC activities for BPN compounds under development in accordance with US regulatory and International Council of Harmonization for Registration of Pharmaceuticals for Human Use [ICH] guidelines. 2. Identify and assess regulatory risks for compounds under development and provide CMC guidance to BPN program and LDTs. Develop Pharmaceutics / Formulation / CMC strategies which accord with US and international guidelines. 3. Provide recommendations for drug substance manufacturing, analytical method development, and process development for small molecules. 4. Provide pharmaceutical sciences expertise in chemical manufacturing, formulation, and product development for small molecules. 5. Assist in ensuring timely preparation, review, and submission of chemical manufacturing and controls documents to regulatory authorities including FDA, European Medicines Agency [EMA] and other national authorities, to support the conduct of clinical trials and marketing applications. 6. Provide expertise in activities related to API development. 7. Recommend dose form selection and API development strategies for BPN efforts. 8. Develop plans to assist BPN staff in strategically managing chemical manufacturing and controls pharmacokinetic programs which facilitate assay development, exploratory chemistry, lead optimization, formulation activities, investigational new drug (IND) enabling, and clinical studies. 9. Accompany NIH staff or visit, at BPN staff request, Contract Research Organizations [CRO] under contract. Inspect facilities and discuss appropriateness of CRO proposed methodology. Submit trip reports to BPN staff. 10. Assist BPN staff to design investigative chemical manufacturing and controls pharmacokinetics studies, including study strategy and experimental design. Provide advice regarding recommended study milestones and prepare milestone reports as needed. 11. Facilitate Lead Development Team discussions via telephone and email regarding assigned drug metabolism and pharmacokinetics efforts.

药剂学/制剂/CMC 药剂学/配方/CMC顾问将通过视频/电话会议和电子邮件向NIH和LDT成员提供执行(高级科学)级别的药剂学/配方/CMC专业知识，并就项目提供反馈和指导。药剂学/配方/CMC顾问的角色可能包括但不限于以下职责和任务： 1.根据美国监管机构和国际人用药物注册协调理事会指南，评估正在开发的BPN化合物的药剂学/配方/CMC活动。 2.识别和评估正在开发的化合物的监管风险，并为BPN计划和LDT提供CMC指导。制定符合美国和国际指南的药品/配方/CMC战略。 3.为药物物质制造、分析方法开发和小分子工艺开发提供建议。 4.在小分子的化学制造、配方和产品开发方面提供药学专业知识。 5.协助确保及时准备、审查和向包括FDA、欧洲药品管理局[EMA]和其他国家当局在内的监管机构提交化学品制造和控制文件，以支持进行临床试验和市场应用。 6.提供API开发相关活动方面的专业知识。 7.为BPN工作推荐剂量形式选择和原料药开发战略。 8.制定计划，协助BPN员工战略性地管理化学制造和控制药代动力学计划，以促进分析开发、探索性化学、先导优化、配方活动、新药研究(IND)和临床研究。 9.陪同NIH工作人员或应BPN工作人员的要求，访问合同下的合同研究组织[CRO]。检查设施并讨论CRO提出的方法的适当性。向BPN员工提交出差报告。 10.协助BPN工作人员设计调查性化学制造和控制药代动力学研究，包括研究策略和实验设计。提供有关推荐研究里程碑的建议，并根据需要准备里程碑报告。 11.通过电话和电子邮件促进Lead开发团队就指定的药物代谢和药代动力学工作进行讨论。