PHARMACEUTICS FORMULATION/CHEMISTRY MANUFACTURING AND CONTROL 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: 10721143
• 负责人: GIAN ARALDI
• 金额: $ 0.71万
• 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/10721143
• 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