SPECIAL NOTICE
A -- Development of Predicitive in Vitro Dissolution/Release Test Methods for Oral Dosage Forms to Assist Product Development and Regulatory Decision-Making
- Notice Date
- 2/20/2009
- Notice Type
- Special Notice
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except 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
- HHS-FDA-RFI-09-001
- Archive Date
- 3/13/2009
- Point of Contact
- Tara R. Hobson,, Phone: 3018279691, Doreen Williams ,, Phone: 3018273366
- E-Mail Address
-
Tara.Hobson@fda.hhs.gov, doreen.williams@fda.hhs.gov
- Small Business Set-Aside
- N/A
- Description
- Date:February 20, 2009 To:FDA Office of Acquisitions and Grants Services Division of Acquisition Operations/Service Contracts From:Arzu Selen, Ph.D. Associate Director, Biopharmaceutics Office of New Drug Quality Assessment Office of Pharmaceutical Science Center for Drug Evaluation and Research Subject:Request for Information RFI: This is a Request for Information (RFI) and is not a Request for Proposal/Request for Quotation (RFP/RFQ) in accordance with FAR 15.201(e). This information is being sought for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of FDA. No official solicitation exists; therefore, please do not request a copy of a solicitation. If in the future an official solicitation is released, there is no guarantee that sources responding to this RFI will be included on the source list. No telephone inquiries will be accepted. Project Title Development of predictive (clinically meaningful) in vitro dissolution/release test methods for oral dosage forms to assist product development and regulatory decision-making including setting drug product dissolution specification Background Information Drug dissolution/release characteristics are critical product attributes and hence, are critical for ensuring that the product performs as described in the target product profile in the target patient population. Currently, dissolution tests are not always predictive of the in vivo drug performance and many issues related to the existing typical dissolution methodologies are raised. There are concerns that despite the advances in technology, the methods and the issues have remained fairly constant over the last several decades. Furthermore, dissolution/release test methods, in general, follow approaches that provide limited information on product characteristics. Recognizing these concerns, alternate dissolution testing methods that are also clinically relevant, are being explored by academia and others for specific products. While these efforts are acknowledged, there is a need to study and develop cohesive "integrated" dissolution/release testing paradigms that will allow building a relationship between the dissolution/release methodology, drug product characteristics and the main sources of variability. In addition to the concerns with dissolution testing methods, poorly soluble drugs represent majority (approximately 70%) of drugs currently in drug development, and API characteristics add to the challenges and opportunities in development of dissolution methods that are reliable, robust and predictive of in vivo drug product performance. Clinically meaningful dissolution methods, also referred to as predictive methods, will improve product quality, interpretation of product related clinical outcomes as well as predict the impact of product related changes on a drug's in vivo performance. Particularly, with implementation of Quality by Design (QbD) principles, promoting science- and risk-based approaches, there is a greater need for clinically relevant, predictive dissolution/release testing, leading to relevant product dissolution/release specification which is critical to product quality, ultimately, patient benefit. This project will also serve as a platform for future studies which will build on the findings from this project. Multiple approaches may evolve from this work, including, incorporation of manufacturing experiments illustrating application of QbD and biopharmaceutics principles to enrich product and process knowledge and understanding, resulting in improved product quality. Purpose: The purpose of this RFI is to identify potential sources that have the capability and qualifications 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 related to 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. FDA is interested in developing and advancing in vitro methodology and practices, and the fulfillment of this effort is in alignment with our mission of protecting and promoting health of the American public. FDA may consider soliciting services for a two-year period, one base year with one option year. RFI Submission Instructions: FDA will not award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted or FDA’s use of such information. Responses will be separated from, and have no bearing on subsequent evaluations of proposals submitted in response to any resulting formal RFP. Eligibility in participating in a future acquisition does not depend upon a response to this notice. Proprietary information is not being solicited. Information considered proprietary, if any, should be identified as such. Responses will be reviewed only by FDA personnel and will be held in a confidential manner. Responses to the RFI should address the following: Part A. Capabilities and Technical Experience – Provide a capability statement describing the ability to develop predictive in vitro dissolution testing for poorly soluble drugs and experience with development and in application of biorelevant in vitro dissolution test methods and experience in lipolysis models. Please consider the following as part of the required work: 1)Development of the research protocol containing the following items a.Selection of drug products Pertinent literature review will be included to support selection of recommended “model” drugs (at least four drugs). Based on drug substance and dosage form characteristics, the “model” drug products for this project will be selected based on the Biopharmaceutics Classification System (BCS), the availability of the API in the market in multiple dosage forms, and that they are extensively studied with numerous literature publications. Poorly soluble drugs that are representatives of BCS II and IV are suitable candidates. Multiple dosage forms of these products will be valuable in testing robustness and flexibility of the in vitro test conditions. b.Development and design of experiments Provide a plan for the basic set of in vitro dissolution experiments utilizing various media, including compendial, biorelavant and appropriate variations for exploring and identifying conditions for IVIVC. c.Data collection approaches and data collection sites Methodology such as study design, data collection, sample and data analyses and related efforts will be according to established methods which will be enhanced by novel approaches, when possible. d. Data analyses approaches and data analyses sites As above, in addition to utilization of established methods, novel approaches will be investigated. e. Communication of data/results and joint publications The finalized a research protocol will include strategy for the experiments as well as communication of data and results. f.Protocol amendments 2)Conduct of research for evaluation of the “model” drugs according to the protocol From the in vitro and in vivo data, where in vivo data will be extracted from publicly available sources, correlations will be explored, with a view to establishing in vitro test methods that can be applied to a wide range of oral dosage forms. Extent of physiological factors on developing robust in vitro in vivo relationships will be explored. 3)Assessment of data and summarizing results according to the protocol 4)Exploring extrapolation of results to other similar products In silico, in vitro and in vitro-in vivo correlation/relationship (IVIVC /IVIVR) based approaches will be employed to explore relationships and develop systematic paradigms that can be applicable across products for developing clinically relevant dissolution testing. Part B. Technical and Management Approach - Provide a capability statement describing how your institution would engage in development and advancement of predictive in vitro dissolution test methods for poorly soluble drugs. Part C. Cost Estimate - Provide a cost estimate for the services and the number of hours in development of predictive in vitro dissolution test methods as described in Part A. Part D. Organizational Conflict of Interest (OCI) - If any, provide disclosure of business activities of your company, your affiliates, your team members and affiliates of your team members which create either a conflict of interest or the appearance of a conflict of interest in the performance of the penetration testing and assessment support services. Part E. Security Requirements – At project completion, while the generated data, information and recommendations are considered public property, describe your ability to provide cleared contractor personnel for the project ensuring data accuracy and integrity. Part F. Business Size – Provide your business size, i.e. small, large, disadvantage business, etc.. Part G. Small Business – Describe your ability to meet the requirements in accordance with 52.219.14 – Limitation on Subcontracting. Responses shall be: identified with the RFI Number; no more than five (5) pages in length; not submitted using marketing materials; submitted to the email as indicated above. FDA makes no implied or in fact contract by issuing this RFI. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the FDA’s view of the information received. Do not send any material that requires a non-disclosure agreement or that may be business sensitive. Responses received that include a non-disclosure agreement or identify information that is business sensitive will not be accepted. Responses to this notice will not be returned.
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