SOLICITATION NOTICE
A -- In Vitro Methods to Assess Therapeutic Equivalence of Topical Products
- Notice Date
- 7/11/2003
- Notice Type
- Solicitation Notice
- 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-FDA39214
- Response Due
- 8/11/2003
- Point of Contact
- Lauren Waller, Contract Specialist, Phone 301-827-7163, Fax 301-827-7151, - Hamilton Brown, Contract Specialist, Phone (301) 827-7043, Fax (301) 827-7101,
- E-Mail Address
-
lwaller@oc.fda.gov, hbrown@oc.fda.gov
- Description
- The Food and Drug Administration (FDA), Center for Drug Evaluation Research (CDER) has a requirement to develop and evaluate an in vitro test protocol that is able to detect changes in manufacturing or formulation when Q1 and Q2 are the same or very similar. If possible a measure for Q3 can be proposed. The FDA has used concepts of Q1, meaning qualitative similarity between generic and reference listed products, and Q2 representing quantitative similarity of composition. These two concepts are not sufficient to say that two products are the same. Thus, Q3 is introduced as a newly defined term that describes similarity of manufacturing process variables resulting in structural similarity and refers to the physical attributes and state of aggregation of the product. The duration of the project will be one year. RFQ available on or about 7/26/03.
- Record
- SN00369500-W 20030713/030711213359 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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