ALBANY MOLECULAR RESEARCH INC - BOZIK BPN 25203

奥尔巴尼分子研究公司 - BOZIK BPN 25203

• 批准号: 10370283
• 负责人: MELISSA ALLARD
• 金额: $ 123.02万
• 依托单位: ALBANY MOLECULAR RESEARCH, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-03-05 至 2024-09-12
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10370283
• 关键词: Clinical Trials; Contractor; Contracts; Data; Development; Documentation; Dosage Forms; Formulation; Grant; Investigational Drugs; Investigational New Drug Application; Label; Molecular; Pharmaceutical Preparations; Pharmacologic Substance; Preparation; Process; Regulation; Research; 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) 建立了蓝图神经治疗网络 (BPN)，以加速发现和开发新药的进程。 BPN 通过拨款和合同支持药物开发过程的每一步，从经过验证的药物到早期临床试验。药物制造和配方计划 (DMFP) 是 BPN 的组成部分，负责开发和制造适用于临床前疗效研究、研究性新药 (IND) 实施研究和临床试验的小分子候选药物剂型。承包商进行活性药物成分 (API) 的工艺开发和制备、预配方和配方研究、分析方法开发和验证、稳定性研究、药品制造、包装、标签、储存和药品分销。该工作根据要求按照现行良好生产规范 (cGMP) 法规进行，并在适当情况下按照良好实验室规范 (GLP) 法规进行。数据和文件以食品和药物管理局 (FDA) 可接受的形式准备，以包含在药物主文件 (DMF)、IND 申请或新药申请 (NDA) 中。