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

A -- ANALYSIS OF INVESTIGATIONAL DRUGS IN BIOLOGICAL FLUIDS - METHOD DEVELOPMENT AND ANALYSIS OF PRE-CLINICAL AND CLINICAL SAMPLES SOL DAMD17-96-R-0030 DUE 051496 POC Contract Specialist Kathy A. Hackley (301) 619-7432 (Site Code DAMD17) The Department of Defense has a need to develop prophylactic and therapeutic drugs for use by its members on modern battlefields. Fundamental to the drug development process is an ability to accurately quantitate drug and major metabolite concentrations in biological fluids such as whole blood, plasma, bile, and urine. This RFP is intended to provide the U.S. Army Medical Research and Materiel Command with analytical assays for quantification of drug and major metabolite concentrations, sample analysis from pre-clinical and clinical efficacy, toxicity, pharmacokinetic, and bioavailability studies, and reports which will support submission of Notice of Claimed Investigational Exemption for a New Drug (IND) and New Drug Application (NDA) to the Food and Drug Administration. The analytical assays shall be performed with dependability, precision, accuracy, and sensitivity to industry standards. All studies must be in compliance with Good Laboratory Practice Regulations. The contractor should be sufficiently flexible so as to be able to develop new assays and analylze study samples from studies of different drugs simultaneously. The contractor must also be able to respond to rapidly changing priorities. The contract will not exceed five years. The RFP, DAMD17-96-R-0030 will be released approximately 1 July 1996. The closing date for receipt of proposals will be approximately 45 days after the RFP is released. Written requests for the RFP package must be submitted to Director, U.S. Army Medical Research Acquisition Activity, ATTN: MCMR-AAA-B, Kathy A. Hackley, Fort Detrick, Frederick, MD 21702-(0155)

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