DEVELOP AND PRODUCE DOSAGE FORMS OF ANTI-AIDS AGENTS

该项目的主要目标是开发和生产 药学上可接受的有前景的新药的非肠道剂型 与抗艾滋病活动有关。通过一次药物选择选择的一些药物 委员会将作为非企业成员被指派负责开发和生产 产品。最初，批次大小预计为第一阶段和第二阶段 II试验。然而，升级到第三/第四阶段的大批量 预计将进行试验和C组分配。据估计，这一点 项目必须准备每年生产数百万个剂量单位。

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.