Production of Td-Cyd Capsules for Clinical Use

Irisys, Inc., San Diego CA

Investigators

Abstract

THE CONTRACTOR WILL MANUFACTURE SIXTEEN HUNDRED (1600) HARD GELATIN CAPSULES OF TD-CYD AT 10 MG STRENGTH UNDER CGMP CONDITION FOR CLINICAL USE BASED UPON THE 16TD084. The batch of product was produced by the contractor and sent to clinical repository. The shelf-life was also evaluated. The drug product will be used in the NCI clinical trials.