SOLICITATION NOTICE
66 -- Development of a bio-relevant dissolution system for in-vitro dissolution testing of drug products. - Soliciation
- Notice Date
- 6/16/2017
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Rockville, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001, United States
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-SOL-1182707
- Point of Contact
- Sarah Hussain, Phone: 2404023796
- E-Mail Address
-
sarah.hussain@fda.hhs.gov
(sarah.hussain@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- Soliciation The objective of this requirement is to acquire a system (a mechanical property tester with torsion and medium bath options that will be used to develop a biorelevant dissolution testing system. This system shall be capable to study dissolution of drug formulations under biorelevant test conditions to better support CDER's NDA/ANDA review process. The requested instrument can also be used to test mechanical properties (bending, shear, fatigue, creep and stress relaxation) of drug products and medical devices. The acquisition of such an instrument will greatly enhance the agency's ability to evaluate biopredictive dissolution models for oral solid dosage formulations and provide recommendations for meaningful dissolution testing parameters.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SOL-1182707/listing.html)
- Place of Performance
- Address: 645 S. Newstead Avenue, St.Louis, Missouri, 63110, United States
- Zip Code: 63110
- Zip Code: 63110
- Record
- SN04547438-W 20170618/170616234354-c24b6bcf766cb92a3857e6f26841f0a0 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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