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DEVELOP AND PRODUCE DOSAGE FORMS OF ANTI-AIDS AGENTS

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
依托单位国家:
美国
项目类别:
财政年份:
1986
资助国家:
美国
项目状态:
已结题
起止时间:
1986-09-30 至 1989-09-29

项目摘要

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中文摘要
翻译
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。
英文摘要
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.
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