IGF::OT::IGF WA: CT003-401-424-003, CLINICAL DRUG SUPPLY, DTP-15-036, 7/1/15 - 12/30/15, TABIBI, PRB

Investigators

Abstract

a. Please conduct a brief formulation work to develop 300 mg strength capsules of IPdR (NSC726188) to determine the capsule size and process of encapsulation. b. Produce twenty six hundred (2600) hard gelatin capsules of IPdR with 300 mg strength according to the formulation developed and approved at step B-a (above) with in process testing. c. Conduct final release test along with Quality Assurance process. d. Prepare labels by consultation with Contract Officer?s Technical Representative e. Package the product into HDPE White containers at 30 counts per bottle, and place suitable size desiccant into each bottle along with either cotton or polyester coil. f. Seal the bottles with induction seal and after capping, quality control check the seals. g. After conducting the Product release test, label the containers and ship the final product to our clinical repository and Shelf-Life Contractor. The number of bottle for shelf life evaluation will be determined later. h. Provide the executed and QA signed batch record as the last deliverable.