IGF::OT::IGF DMFP - TASK ORDER NO. 2 PETRUKHIN BPN-14967

IGF::OT::IGF DMFP - 任务订单号

• 批准号: 9163172
• 负责人: JOHN REILLY
• 金额: $ 99.06万
• 依托单位: ALBANY MOLECULAR RESEARCH, INC.
• 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/9163172
• 关键词: Age related macular degeneration; All-Trans-Retinol; Animal Model; Atrophic; Binding; Binding Sites; Biological Assay; Blood Circulation; Clinical Trials; Complex; Contractor; Contracts; Cytoplasmic Granules; Data; Development; Documentation; Dosage Forms; Drug Formulations; Drug Kinetics; Goals; Grant; Investigational Drugs; Investigational New Drug Application; Label; Legal Blindness; Lipofuscin; Mediating; Neurodegenerative Disorders; Neurons; Pharmaceutical Chemistry; Pharmaceutical Preparations; Pharmacologic Substance; Phase I Clinical Trials; Photoreceptors; Poison; Prealbumin; Preparation; Process; Production; Regulation; Retina; Retinal Cone; Retinol Binding Proteins; Safety; Serum; Specificity; Staging; Structure of retinal pigment epithelium; Testing; United States Food and Drug Administration; United States National Institutes of Health; Validation; Wallerian Degeneration; Work; analytical method; clinical efficacy; cytotoxic; drug candidate; drug development; drug distribution; glomerular filtration; good laboratory practice; inhibitor/antagonist; macula; method development; pre-clinical; preclinical efficacy; programs; retinal rods; small molecule; uptake; visual cycle

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通过拨款和合同支持药物开发过程的每一步，从验证成功到早期临床试验。药物制造和配方计划（DMFP）是BPN的一个组成部分，负责开发和制造适合临床前疗效研究、研究性新药（IND）研究和临床试验的小分子候选药物剂型。承包商负责原料药（API）的工艺开发和制备、预制剂和制剂研究、分析方法开发和验证、稳定性研究、药品生产、包装、标签、储存和分销。本工作按照现行良好生产规范（cGMP）的规定进行，并在适当情况下按照良好实验室规范（GLP）的规定进行。数据和文件以食品和药物管理局（FDA）可接受的形式准备，以便纳入药物主文件（DMF）， IND申请或新药申请（NDA）。