SOLICITATION NOTICE
A -- In Vivo- In Vitro Correlation
- Notice Date
- 7/21/2009
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541711
— Research and Development in Biotechnology
- 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
- 1058766
- Archive Date
- 8/20/2009
- Point of Contact
- Jaclyn Stielper, , Doreen Williams ,
- E-Mail Address
-
jaclyn.stielper@fda.hhs.gov, doreen.williams@fda.hhs.gov
(jaclyn.stielper@fda.hhs.gov, doreen.williams@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6, simplified acquisition procedures and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-30. This announcement constitutes the only 100% small business set aside solicitation and a written solicitation will not be issued. This synopsis, NAICS code 541711, is to notify contractors that the government intends to issue a Firm Fixed Price Purchase Order in accordance with FAR Part 13.106 for the following statement of work, under the simplified acquisition procedures. Any firm that believes it is capable of providing the required service as stated herein may submit a capability statement to document its ability to provide the required services. A determination to compete this procurement based on a response to this notice is solely within the discretion of the Government. The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial offer(s) is/are providing the Best Value and discussions are not necessary. Award will be made to the party whose quote offers the best value to the Government, technical, price, and other factors considered. The Government may award this contract to other than the lowest price technically acceptable quote. The Government will evaluate information based on the following evaluation criteria: 1) Technical Capability factor described to "Meet or Exceed the Requirement," 2) Past Performance and 3) Price. Technical Capability and Past Performance, when combined, are significantly more important than price. This solicitation is issued as a Request for Quote (RFQ). The Food and Drug Administration (FDA) intends to award a purchase order for the development of dissolution method strategies with an in vivo-in vitro correlation for formulations of poorly soluble compounds. General Duties/Description of Work Background Realization of the QbD paradigm requires a systematic framework for developing dissolution methods for poorly soluble compounds. Characterizing the drug-release mechanism by establishing an in vitro dissolution test method to measure product performance is particularly important for poorly soluble compounds. For a development compound, dissolution testing is used primarily to help develop and evaluate new formulations by evaluating the rate of drug release from dosage forms, evaluating the stability of these formulations, monitoring product consistency, assessing formulation changes, and establishing In-vitro In-vivo relationships or correlations (IVIVRs or IVIVCs respectively). One of the most difficult aspects of drug development of poorly soluble compounds is the development of appropriate dissolution methods for these systems. In many cases, the parent molecule crystallizes during the dissolution test making the rate of dissolution abnormally slow. Thus, for poorly soluble compounds, dissolution tests are often empirically derived and may have no relationship to product quality. Because of this empiricism, the meaning and significance of dissolution failures is not clear. In such cases achieving quality by design is not possible. Without dissolution methods, formulation design and development is also not possible. Additionally, specifications may not be reflective of product quality or manufacturing reproducibility. For a commercial product, dissolution testing is used primarily to confirm manufacturing and product consistency, to evaluate the quality of the product during its shelf life, and to assess post-approval changes and the need for bio-equivalency studies. Objective The long range goal of this work is to establish a new toolkit for developing dissolution tests that are reflective of in-vivo performance of formulations of poorly soluble drugs. This toolkit involves: (1) the use of surfactant screens to select the best media; (2) Small-scale tests will be carried out to assess the effect of crystallization of the parent drug during the test; (3) An additive screen to find an additive to prevent premature crystallization; (4) Scale up of the method and testing at full scale; and (5) comparison of dissolution data to in-vivo results. This toolkit will provide technologies to develop a QbD dissolution test which correlates with in vivo blood levels of the drug (IVIVC in-vitro in-vivo correlation). The goal of this contract is to establish preliminary feasibility of the strategy. This study is important because of the recent emphasis on quality by design. The contractor will focus on the poorly soluble drug itraconazole. Although there are 4 common approaches to preparing a formulation of poorly soluble drugs with enhanced bioavailability: (1) cocrystals, (2) amorphous forms, (3) salts, and (4) nanocrystals, this project will focus on amorphous forms. This study is aimed at determining the feasibility of an in vitro dissolution method that is reflective of in-vivo performance of amorphous dispersions of itraconazole. The contractor will carry out a model dissolution test development project on itraconazole dispersions. Stability of these formulations will be determined using stress testing designed by the contractor with approval of the FDA COTR. This amorphous dispersion will be scaled-up and then this dispersion will be subjected to a surfactant screen and a solvent screen. The preference is to use a surfactant in water system. The appropriate solvents and surfactants will then be screened for crystallization potential. In this study the solutions produced during the dissolution test will be stirred for 8 hours and the extent of crystallization measured visually. Amorphous itraconazole without polymers will be used as the control. Various polymers (at least 2) will be screened for their ability to prevent crystallization in an 8 hour test. In this test the solutions after dissolution will be stirred for 8 hours and observed/analyzed for crystallization. The timeframe may be adjusted if needed. The ability of this inhibitor to prevent crystallization at a given concentration (e.g. 10%) will be determined, initially in a simple yes-no test. Amorphous itraconazole will be used as the control. Description of Work/Deliverables Activity...Deliverable...Timeline 1Detailed work plan...Report...1 month 2Initial platform for developing dissolution tests with IVIVC for poorly soluble compound...Report...Qtr 3 3Preliminary information on an IVIVC for itraconazole...Report...Qtr 3 4Final Project Report and Presentation to the FDA...Final Report and Presentation...15 months from start of the project Period of Performance 15 months from date of award. Place of Performance Work shall be performed at the Contractor’s facility. Travel may be needed to the FDA site to attend meetings. Telephone conferences may also be held. CCR: Vendors must be registered in the Central Contractor Register (CCR) prior to the award of a contract. You may register by going to www.ccr.gov. You will need your Dun & Bradstreet number and banking information. QUESTIONS DEADLINE: All questions are to be submitted via email to Jaclyn.Stielper@fda.hhs.gov no later than July 31, 2009 at 4:30 PM EST. QUOTATIONS DUE: All quotations are due, via email to: Jaclyn.Stielper@fda.hhs.gov, no later than 4:30 PM EST on August 5, 2009. PROVISIONS and CLAUSES: The provision at FAR 52.212-1, Instructions to Offerors Commercial Items applies to this solicitation. The following agenda has been attached to this provision: None. Offerors shall include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications Commercial Items. The clause at FAR 52.212-4, Contract Terms and Conditions, Commercial Items applies to this acquisition. The following agenda has been attached to the clause: None. The clause at FAR 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders, Commercial Items applies to this acquisition. The following FAR clauses cited are applicable: FAR 52.217-8, FAR 52.217-9, FAR 52.222-26, FAR 52.222-35, FAR 52.222-36, and FAR 52.232-33. Clauses and provisions are incorporated by reference and apply to this acquisition. Responses to this notice must be sent via email to Jaclyn.Stielper@fda.hhs.gov. Telephone calls will not be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/1058766/listing.html)
- Place of Performance
- Address: Contractor's Facility, United States
- Record
- SN01882689-W 20090723/090722001811-e07ca79499832a7b8bcfb113cb85ee06 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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