The objective of this resource function is to develop and produce pharmaceutically acceptable dosage forms of promising new agents with anti-AIDS activity. Some agents selected by a Drug Selection Committee at NIH will be assigned for development and manufacture as oral products. Initially, the batch sizes are expected to be small for 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 oral dosage units each year.
