SOLICITATION NOTICE
A -- Therapeutic Equivalence of Topical Products
- Notice Date
- 4/30/2004
- Notice Type
- Solicitation Notice
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- 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
- 223-04-3004
- Response Due
- 7/5/2004
- Archive Date
- 7/20/2004
- Point of Contact
- Hamilton Brown, Contract Specialist, Phone (301) 827-7043, Fax (301) 827-7101,
- E-Mail Address
-
hbrown@oc.fda.gov
- Description
- Despite considerable efforts by both the generic industry and the FDA for the past decade, few topical generic products are currently available on the US market. This is partly due to the unavailability of a cost-effective, scientifically sound system to evaluate the therapeutic equivalence of topical products. For example, the bioequivalence demonstration of many topical products relies on clinical trials that may require hundreds of patients (due to high variability of the patient population). Even with large study sizes, these costly studies may have to be repeated to meet the confidence interval criteria to demonstrate bioequivalence. As part of a system to assess therapeutic equivalence of topical products without using clinical trials, in vivo tests that evaluate product performance are needed. Skin stripping techniques apply a topical product to the skin, remove the product after a specified time, and then remove the top layers of the skin and measure the amount of drug present in these layers. In FY2003 a preliminary study (phase I) was funded to improve the skin stripping procedure by mapping the sources of variability and quantification of variability in different stages of the method. There were two aspects to the phase I of the project: analysis of variability in various experimental strategies using existing data and methodology and a preliminary pilot experimental study. In this project (phase II), a pivotal study is planned to use the results of the first study to develop a new skin stripping methodology. There are four aspects to phase II of the project: 1. Use of the phase I results to define a protocol for the pivotal study, 2. Pivotal experimental study, 3. Mathematical simulation and modeling of absorption, distribution, metabolism and clearance from topical applications and 4. Development of a revised skin stripping protocol and methodology, for assessing the equivalence of topical formulations. The results of this project will evaluate the ability of an improved skin stripping procedure to differentiate between bio-availabilities of the test and reference products and measure, in vivo, the key physical properties that control the delivery of a drug from a topical drug product. This study will compare several test products to a reference product. The reference product will be a marketed product while the first test product will be a manufactured product provided by the FDA. The second test product will be a product that has been demonstrated to be clinically equivalent to the reference product. The ability of skin stripping to measure alterations in skin partition and diffusion induced by formulation differences will be evaluated. Mathematical simulation, modeling and statistical analysis of the variability in various experimental strategies will be used to define an improved skin stripping methodology. This project will result in validation of an improved protocol and methodology that describes how to use the skin striping method to determine bio-equivalence of topical products. It is anticipated that a cost reimbursement type contract will be awarded for a period of two years in September 2004. A successful outcome of Phase II of the project will enable the agency to recommend a suitable bio-equivalence method for topical drug products. The bio-equivalence method will be published in a draft-guidance for industry. This is not a Request for Proposals (RFP). THIS SOLICITATION WILL BE AVAILABLE ELECTRONICALLY ONLY. Request for Proposal will be available electronically and may be accessed through the FedBizOpps (URL: http://www.fedbizopps.gov) 15 or more calendar days after the issuance of this synopsis. OFFERORS ARE RESPONSIBLE FOR ROUTINELY CHECKING THIS WEBSITE FOR ANY POSSIBLE SOLICITATION AMENDMENTS THAT MAY BE ISSUED. NO INDIVIDUAL NOTIFICATION OF ANY AMENDMENTS WILL BE PROVIDED. All responsible sources may submit a proposal, which shall be considered by the agency.
- Place of Performance
- Address: Contractor's site
- Record
- SN00577535-W 20040502/040430211805 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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