BI-COMPARTMENT TRANSDERMAL CONTRACEPTIVE DELIVERY SYSTEM NIH GUIDE, Volume 21, Number 11, March 20, 1992 RFP AVAILABLE: NICHD-CD-92-11 P.T. 34 Keywords: Contraceptives Dosage Forms+ Hormones National Institute of Child Health and Human Development The Contraceptive Development Branch, Center for Population Research, National Institute of Child Health and Human Development, has a requirement for the development of a bi-compartment transdermal contraceptive system capable of delivering a progestin from one compartment and an estrogen from the other compartment in such a way that the delivery of progestin(s) will be independent of the delivery of the estrogen and vice versa. The overall size of the bi-compartment transdermal contraceptive system should be about 10cm2. The objective of the project is to design and develop a transdermal contraceptive system that will have the potential of (1) using one of the several progestins currently used in various oral contraceptive formulations and estradiol-17beta as the estrogen, (2) delivering the progestin or the estrogen alone, and (3) changing the delivery of the progestin(s) and/or the estrogen without affecting the delivery of the other drug. The blood concentration of the contraceptive drug(s) must be comparable to that achieved through oral contraceptive regimen(s) containing that progestin. Organizations (and their collaborators, if any) must have adequate facilities to perform all necessary in vitro and in vivo animal studies preliminary to filing an Investigational New Drug (IND) application with the Food and Drug Administration, conduct Phase I Clinical Studies, and supply a sufficient number of the bi-compartment transdermal delivery systems for Phase II studies. The Phase II studies will not be a part of this project. This announcement is not a Request for Proposals (RFP). The RFP will be issued on or about March 20, 1992. Proposals will be due approximately 60 days thereafter. NICHD expects to fund two contracts from this solicitation. Copies of RFP may be obtained by sending written requests to: Paul J. Duska, Contracting Officer Contracts Management Branch, OGC National Institute of Child Health and Human Development Executive Plaza North, Room 610 9000 Rockville Pike Bethesda, MD 20892-9903 FAX: (301) 402-0915 .
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