SOLICITATION NOTICE
B -- Development of Immediate Release Oral Formulations Using the Concept of Quality by Design and Predicting In Vivo and In Vitro Correlations for Class II (Low Solubility, High Permeable) Drugs in Dogs and Humans
- Notice Date
- 6/11/2008
- Notice Type
- Presolicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical 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, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA1041864A
- Point of Contact
- Patricia Wright,, Phone: 301-827-7217
- E-Mail Address
-
patricia.wright@fda.hhs.gov
- Small Business Set-Aside
- N/A
- Description
- The Food and Drug Administration (FDA) is seeking proposals for a contractor to fulfill a requirement for a program titled: Development of Immediate Release Oral Formulations Using the Concept of Quality by Design and Predicting In Vivo and In Vitro Correlations For Class II (Low Solubility, Highly Permeable) Drugs in Dogs and Humans. The potential contractor must have the technical expertise which encompasses experience with generating in vivo/in vitro correlations (IVIVC), an understanding of the Biopharmaceutics Classification System (BCS) and its applicability to the factors influencing product performance, expertise in the manufacture of solid oral dosage forms and design space issues, experience with on/at line monitoring system (eg., near infra red spectroscopy (NIR) and chemometric modeling), expertise in developing in vitro dissolution methods, and an ability to develop and validate the analytical methods needed to quantify the drug concentrations in incurred (blood ) samples and the in vitro dissolution medium. The potential contractor must own or have access to the facilities needed to manufacture oral dosage forms, dose human volunteers [intravenous (IV) and oral (PO) drug administration), dose dogs (IV and PO), collect blood, and conduct in vitro test procedures. The facility MUST BE within the Washington, DC – Baltimore, Maryland metropolitan vicinity. The potential contractor must have the staff needed to execute the blood sampling, dosing, assays and product testing and also support product formulation development and clinical studies. FDA anticipates an award of a single cost reimbursement completion type contract with a maximum term of 30 months. FDA intends to solicit this requirement as a full and open competitive requirement. The solicitation will be available for download on or about June 24, 2008 and may be accessed through the Federal Business Opportunities (FedBizOpps) website. No hardcopies will be distributed. Any questions concerning this requirement must be submitted in writing by e-mail only, to Patricia Wright at patricia.wright@fda.hhs.gov. NO PHONES WILL BE ACCEPTED. All responsible sources may submit a proposal which will be considered by the Agency.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=0b55414f40659b9e449ae6ee71e5647b&tab=core&_cview=1)
- Record
- SN01591028-W 20080613/080611221312-0b55414f40659b9e449ae6ee71e5647b (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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