DEVELOPMENT AND PRODUCTION OF PARENTERAL DOSAGE FORMS

肠胃外剂型的开发和生产

• 批准号: 2300406
• 负责人: TIMOTHY D SMITH
• 金额: $ 157万
• 依托单位: BEN VENUE LABORATORIES, INC.
• 依托单位国家: 美国
• 财政年份: 1992
• 资助国家: 美国
• 起止时间: 1992-05-01 至 1997-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2300406
• 关键词: DEVELOPMENT; PRODUCTION; PARENTERAL; DOSAGE; FORMS

The contractor shall develop and produce sterile clinical drug supplies of various batch sizes to include freeze dried parenterals, liquid filled parenterals, ampules, and occasionally large volume parenterals intended for human use. The contractor's facilities must be FDA inspected and in compliance with good manufacturing practices and all FDA drug requirements. The contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, facilities, testing, certificates of analysis, and final reports required to support NCI's Investigational New Drug Applications (INDs) files with the Food and Drug Administration (FDA). In addition, the contractor shall provide adequate analytical instrumentation to perform complete quality control of both new drug substances and formulated products. Finally the contractor shall be responsible for packaging, labeling, properly storing, and shipping all products produced by the contract.

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