DIRECTOR, USAMRAA, MCMR-AAA, BLDG 820, FORT DETRICK, FREDERICK MD 21702-5014

A -- A--PRE-FORMULATION STUDIES AND FORMULATION OF INVESTIGATIONAL NEW DRUG SOL DAMD17-97-R-0001 DUE 123196 POC Contract Specialist Nancy G. Mohler (301) 619-7424 (301) 619-2937 FAX Contracting Officer Patricia M. McAllister (301) 619-7360 (Site Code DAMD17) (Site Code DAMD17) The U.S. Army Medical Research and Materiel Command (USAMRMC) has as one of its responsibilities the development of new drugs to protect or treat soldiers confronted with threats on the modern battlefield or exposed to endemic diseases during deployment. Preformulation studies and formulation development are needed in the early stage of drug development. During the clinical study phases, production and delivery of clinical batches of formulated products are required. A contractor is needed (1) to determine the essential physical and chemical properties of candidate drugs with the ultimate goal of designing an optimal dosage form or drug delivery system, (2) to design, formulate, test, and produce clinical batches of solid oral, parenteral, or other dosage forms to support phase I, II, and III clinical trials. All studies and productions must be in compliance with the current Good Manufacturing Practice (cGMP) Regulations and be performed in an FDA-licensed facility. The contractor should be sufficiently flexible so as to be able to study more than one candidate drug and drug formulations simultaneously. The contractor must also be able to respond rapidly to(0319)

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