MCNAMARA EXPLORATORY CHEMISTRY

麦克纳马拉探索化学

• 批准号: 10158253
• 负责人: MELISSA ALLARD
• 金额: $ 126.88万
• 依托单位: ALBANY MOLECULAR RESEARCH, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-05-01 至 2021-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10158253
• 关键词: Chemistry; Clinical Trials; Contractor; Contracts; Data; Development; Documentation; Dosage Forms; Formulation; Grant; Investigational Drugs; Investigational New Drug Application; Label; Pharmaceutical Preparations; Pharmacologic Substance; Preparation; Process; Regulation; United States Food and Drug Administration; United States National Institutes of Health; Validation; Work; analytical method; drug candidate; drug development; drug distribution; early phase clinical trial; efficacy study; good laboratory practice; method development; novel therapeutics; preclinical efficacy; programs; small molecule; support network

The National Institutes of Health (NIH) established the Blueprint Neurotherapeutics Network (BPN) to accelerate the process of discovering and developing new drugs. The BPN supports, through grants and contracts, every step of the drug development process from validated hits through early clinical trials. The Drug Manufacturing and Formulation Program (DMFP), a component of the BPN, conducts the development and manufacture of dosage forms of small molecule drug candidates suitable for administration in preclinical efficacy studies, Investigational New Drug (IND) enabling studies, and clinical trials. Contractors conduct process development and preparation of active pharmaceutical ingredients (API), pre-formulation and formulation studies, analytical method development and validation, stability studies, drug product manufacturing, packaging, labeling, storage, and distribution of the drug products. The work is conducted in accordance with Current Good Manufacturing Practices (cGMP) regulations as required and where appropriate in accordance with Good Laboratory Practice (GLP) regulations. Data and documentation are prepared in a form acceptable to the Food and Drug Administration (FDA) for inclusion in a Drug Master File (DMF), IND application, or New Drug Application (NDA).

美国国立卫生研究院（NIH）建立了蓝图神经疗法网络（BPN），以加速发现和开发新药的过程。 BPN通过赠款和合同支持药物开发过程的每一步，从经过验证的命中到早期临床试验。 BPN的一个组成部分的药物制造和制剂计划（DMFP）进行了适合在临床前效能研究，研究新药（IND）启用研究和临床试验的小分子药物候选剂型的剂型的开发和制造。 承包商在进行过程开发和准备活动药物成分（API），制定和配方研究，分析方法开发和验证，稳定性研究，药物制造，包装，标签，存储，存储和分布。 这项工作是根据当前的良好制造实践（CGMP）法规进行的，并根据良好的实验室实践（GLP）法规进行。 数据和文档以食品药物管理局（FDA）可接受的形式准备，以纳入药物主文件（DMF），IND应用或新药应用（NDA）。