IGF::OT::IGF Development & Manufacture of Pharmaceutical Products for the Treatment of Substance Abuse Disorcer. NIDA Ref. No. N01DA-16-8926; POP: 09/18/2016 - 09/17/2021.

IGF::OT::IGF 开发

• 批准号: 9430319
• 负责人: RAM MURTY
• 金额: $ 69.76万
• 依托单位: MURTY PHARMACEUTICALS, INC.
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-18 至 2021-09-17
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9430319
• 关键词: Clinical; Clinical Research; Communities; Contractor; Cyclic GMP; Development; Documentation; Dosage Forms; Drug Incompatibility; Ensure; Excipients; Formulation; Investigation; Investigational Drugs; Investigational New Drug Application; Label; National Institute of Drug Abuse; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Production; Quality Control; Regulation; Research; Testing; United States Food and Drug Administration; Validation; design; experience; insight; novel therapeutics; pre-clinical; substance abuse treatment

Management of New Project Tasks: As an incumbent contractor, MPI offers experience for the management of new project tasks. Preformulation Studies I: The investigations in this task will identify potential formulation/analytical challenges and/or development strategies. Preformulation Studies II: The investigations will assist in the selection of appropriate excipients and provide insight into potential incompatibilities for the drug products. Dosage Form Development Studies: Formulation studies will result in the appropriate design of useful preclinical and clinical formulations.

新项目任务管理：作为现有承包商，MPI为新项目任务的管理提供了经验。 拟订前研究I：这项任务的调查将确定潜在的拟订/分析挑战和/或发展战略。 制剂前研究II：调查将有助于选择适当的辅料，并为药物产品的潜在不相容提供洞察力。 剂型开发研究：配方研究将导致有用的临床前和临床配方的适当设计。