DEVELOP AND PRODUCE DOSAGE FORMS OF ANTI-AIDS AGENTS

抗艾滋病剂剂型的开发和生产

• 批准号: 3614274
• 负责人: DAVID W FLAMBERG
• 金额: $ 52.34万
• 依托单位: BEN VENUE LABORATORIES, INC.
• 依托单位国家: 美国
• 财政年份: 1986
• 资助国家: 美国
• 起止时间: 1986-09-30 至 1989-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3614274
• 关键词: AIDS; antiAIDS agent; biological products; dosage forms; drug administration routes; drug metabolism; immunopharmacology

The primary objective of this project is to develop and produce pharmaceutically acceptable parenteral dosage forms of promising new agents with anti-AIDS activity. Some agents selected by a Drug Selection Committee will be assigned for development and production as a parenteral product. Initially, the batch sizes are expected to be small phase I and II trials. However, escalation to large batch sizes for phase III/IV trials and Group C distribution is anticipated. It is estimated that this project must be prepared to produce several million dosage units each year.

该项目的主要目标是开发和生产 有希望的新药剂的药学上可接受的肠胃外剂型 抗艾滋病活动。 药物选择选择的一些药物 将指定委员会作为胃肠外制剂进行开发和生产 产品 最初，批次规模预计将是小的第一阶段， 第二次审判。 然而，III/IV期研究的批量规模扩大 预计将进行审判和C组分配。 估计这 该项目必须准备每年生产数百万剂量单位。