SOLICITATION NOTICE
B -- Development of Predictive in Vitro Dissolution/Release Test Methods
- Notice Date
- 4/10/2009
- Notice Type
- Presolicitation
- NAICS
- 541690
— Other Scientific and Technical 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, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-SOL-09-1055789
- Archive Date
- 6/16/2009
- Point of Contact
- Tara R. Hobson,, Phone: 3018279691, Doreen Williams ,, Phone: 301-827-3366
- E-Mail Address
-
Tara.Hobson@fda.hhs.gov, doreen.williams@fda.hhs.gov
- Small Business Set-Aside
- N/A
- Description
- The FDA intends to issue a Request for Quotation (RFQ) to establish a collaborative project with qualified organization(s) to develop and perform predictive in vitro dissolution/release test methods. The purpose of this contract is to establish a collaborative project with qualified organization(s) to develop and perform predictive in vitro dissolution/release test methods that can be applicable for poorly soluble drugs, and guide in vitro and in vivo studies conducted for APIs with similar solubility characteristics under typical (standard) conditions and under “altered” conditions reflecting unique patient characteristics. The developed dissolution/release testing paradigms, incorporating drug product and dosage form characteristics for oral dosage forms, should be reliable, transferable to similar products, and clinically meaningful (predictive) throughout the lifecycle of the product. Furthermore, while addressing existing concerns, the approaches explored will bring in new knowledge, and it is intended that the findings from this project (with necessary extensions), will lead to in vitro dissolution/release testing paradigms for a large group of drug products. The work under this contract involves preparation of a study protocol that will describe the rationale in selection of the study drugs (will be referred to as model drugs), methods (such as methods used for data collection and possible additional exploratory approaches, data storage and data analyses) and reporting and communication of results. The subsections of the study protocol and the required information are described as follows. The study protocol will guide the research so it will be completed prior to initiation of the experimental work. During conduct of research, if revisions to the protocol are needed, such as incorporating additional analyses, the supporting rationale and methodology will be described and added to the study protocol as amendments. The study protocol will serve as the overall plan for the research program with details supporting key decision steps. The anticipated award type is a firm fixed price contract for Five (5) Years; One Base Year with Four Option Year. This contract will be full and open competition. The contract will be awarded best value (lowest price, technically acceptable). The designated North American Industry Classification System (NACIS) code is 541690- Other Scientific and Technical Consulting Services. All vendors must be registered in the Central Contractor Registry (CCR) prior to award of a federal contract. The website is www.ccr.gov. This announcement is not an RFQ. Interested parties shall submit an email to Tara.Hobson@hhs.fda.gov to request a copy of the solicitation. The release of the solicitation will be on or about May 1, 2009. The response date will be on or about June 1, 2009.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=7bc1e0341c99b3f10ac2fdc57a491bce&tab=core&_cview=1)
- Record
- SN01790631-W 20090412/090410220501-7bc1e0341c99b3f10ac2fdc57a491bce (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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