IGF::OT::IGF DRUG MANUFACTURING AND FORMULATION PROGRAM (DMFP) TASK ORDER #01: PERFORMANCE ACTIVITY 1 TECHNICAL SUPPORT (1/15/15 1/14/16)

IGF::OT::IGF 药品制造和配方计划 (DMFP) 任务单

• 批准号: 10788084
• 负责人: ALAN CARTER
• 金额: $ 6.15万
• 依托单位: MIDWEST RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-01-15 至 2025-01-14
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10788084
• 关键词: Acceleration; Clinical Trials; Contractor; Contracts; Data; Development; Documentation; Dosage Forms; Formulation; Good Manufacturing Process; 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; manufacture; method development; nervous system disorder; 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过程。BPN通过赠款和合同支持药物开发过程的每一步，从验证的命中到早期临床试验。药物生产和制剂计划（DMFP）是BPN的一个组成部分，负责开发和生产适用于临床前疗效研究、研究性新药（IND）使能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、处方前和处方研究、分析方法开发和验证、稳定性研究、制剂生产、包装、贴标、储存和制剂分销。本工作根据现行药品生产质量管理规范（cGMP）法规（如需要）和药物非临床研究质量管理规范（GLP）法规（如适用）进行。数据和文件以美国食品药品监督管理局（FDA）可接受的形式编制，以纳入药物主文件（DMF）、IND申请或新药申请（NDA）。