DHHS/PHS/FDA/Office of Facilities, Acquisitions and Central Services, Contracts Operations Branch, HFA-512, 5600 Fishers Lane, Park Bldg, Rm 3-32, Rockville, MD 20857

A -- DISSOLUTION TESTING AS A PROGNOSTIC TOOL FOR ORAL DRUG ABSORPTION SOL FDA 243816-95 DUE 092795 POC Contact Contract Specialist, Trudy Dartouzos or Paul Scarborough, Contracting Officer, 301/443-4420, FAX 301-443-3651 The Food and Drug Administration (FDA) intends to award a purchase order for research to develop dissolution testing for immediate release products that can serve as a predictor for in vivo performance of the product. Dissolution testing should be carried out in physiologically based medium under physiologically based criteria and conditions. The physiologically based media should simulate fasted and fed conditions of the GI mileau. The test conditions should also reflect the temporal patterns of GI conditions in both fasted and fed states. Tests will be: aqueous buffers, physiologically based media which simulate fasted state intestinal media, physiologically based media which simulate fed state intestinal conditions, and physiologically based media simulating temporal patterns of GI conditions in the fasted and fed states. Written quotations required by COB 9/27/95. (0242)

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