SOLICITATION NOTICE
R -- Study on In-Vitro Methods to Assess Structural Similarity of Topical Products
- Notice Date
- 6/14/2004
- Notice Type
- Solicitation Notice
- NAICS
- 541618
— Other Management Consulting Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, MD, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- Reference-Number-D3916204
- Response Due
- 6/30/2004
- Archive Date
- 7/15/2004
- Point of Contact
- Barbara Kennedy, Contract Specialist, Phone 301-827-7166, - Hamilton Brown, Contract Specialist, Phone (301) 827-7043, Fax (301) 827-7101,
- E-Mail Address
-
barbara.kennedy@oc.fda.gov, hbrown@oc.fda.gov
- Description
- The Food and Drug Administration intends to issue a non-competitive, sole source purchase order to the University of Kentucky. Objective - Objectives of this project extension are to evaluate the use of the Franz diffusion cell as part of the bioequivalence criterion for topical products. Different membrane types will be evaluated and the ability of the diffusion cell to detect differences in product attributes due to differences in the manufacturing process between test and reference products. Detailed Description - In the previous part of this project test products that were Q1 and Q2 identical were manufactured under controlled conditions with known modifications. A variety of tests were applied to these products. Based on these results and discussions at the FDA advisory committee, further evaluation of the Franz diffusion cell is desired. The test products from the previous work shall be evaluated in the Franz diffusion cell using low resistance and high resistance artificial membranes as well as cadaver skin membranes. It is desired to find the optimal membrane for two cases: Detecting formulations (Q3) differences in products that at Q1 and Q2 to each other Detecting differences in thermodynamic activity of the drug substance in products that have Q1 and/or Q2 differences. The University of Kentucky shall verify these tests by applying them to a variety of topical products (gels, lotions, creams, ointments) that are Q1 and Q2 different and also to products that are Q1 and Q2 similar but differ in a controlled manner through changes to a manufacturing process. Measurements shall be repeated over a time period to evaluate the variation. The period of performance is for one year. This not a request for quotes. However, other bidders/offers who believe they posses the capabilities and expertise to perform this work must respond to the responsible contract specialist prior to the response due date. The FDA?s evaluation/award will be based on the technically acceptable quote that offers the best value to the Government. The sole source procurement will be awarded as a simplified acquisition in accordance with FAR 13.5
- Record
- SN00602798-W 20040616/040614211718 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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