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The Role of Model M...
The Role of Model Master Files for Sharing, Acceptance, and Communication with FDA
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- Fang, Lanyan (författare)
- US FDA, Ctr Drug Evaluat & Res, Div Quantitat Methods & Modeling, Off Res & Stand,Off Gener Drugs, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
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- Gong, Yuqing (författare)
- US FDA, Ctr Drug Evaluat & Res, Div Quantitat Methods & Modeling, Off Res & Stand,Off Gener Drugs, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
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- Hooker, Andrew, 1973- (författare)
- Uppsala universitet,Institutionen för farmaci
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- Lukacova, Viera (författare)
- Simulat Plus Inc, Lancaster, CA USA.
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- Rostami-Hodjegan, Amin (författare)
- Univ Manchester, Ctr Appl Pharmacokinet Res, Manchester, England.;Certara Inc, Princeton, NJ USA.
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- Sale, Mark (författare)
- Certara Inc, Princeton, NJ USA.
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- Grosser, Stella (författare)
- US FDA, Ctr Drug Evaluat & Res, Div Biostat 8, Off Biostat,Off Translat Sci, Silver Spring, MD USA.
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- Jereb, Rebeka (författare)
- Lek Pharmaceut Dd, Ljubljana, Slovenia.
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- Savic, Rada (författare)
- Univ Calif San Francisco, Dept Bioengn & Therapeut Sci, San Francisco, CA USA.
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- Peck, Carl (författare)
- NDA Partners LLC, Washington, DC USA.;Univ Calif San Francisco, Dept Bioengn & Therapeut Sci, San Francisco, CA USA.
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- Zhao, Liang (författare)
- US FDA, Ctr Drug Evaluat & Res, Div Quantitat Methods & Modeling, Off Res & Stand,Off Gener Drugs, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
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US FDA, Ctr Drug Evaluat & Res, Div Quantitat Methods & Modeling, Off Res & Stand,Off Gener Drugs, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA Institutionen för farmaci (creator_code:org_t)
- Springer, 2024
- 2024
- Engelska.
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Ingår i: AAPS Journal. - : Springer. - 1550-7416. ; 26:2
- Relaterad länk:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- With the evolving role of Model Integrated Evidence (MIE) in generic drug development and regulatory applications, the need for improving Model Sharing, Acceptance, and Communication with the FDA is warranted. Model Master File (MMF) refers to a quantitative model or a modeling platform that has undergone sufficient model Verification & Validation to be recognized as sharable intellectual property that is acceptable for regulatory purposes. MMF provides a framework for regulatorily acceptable modeling practice, which can be used with confidence to support MIE by both the industry and the U.S. Food and Drug Administration (FDA). In 2022, the FDA and the Center for Research on Complex Generics (CRCG) hosted a virtual public workshop to discuss the best practices for utilizing modeling approaches to support generic product development. This report summarizes the presentations and panel discussions of the workshop symposium entitled "Model Sharing, Acceptance, and Communication with the FDA". The symposium and this report serve as a kick-off discussion for further utilities of MMF and best practices of utilizing MMF in drug development and regulatory submissions. The potential advantages of MMFs have garnered acknowledgment from model developers, industries, and the FDA throughout the workshop. To foster a unified comprehension of MMFs and establish best practices for their application, further dialogue and cooperation among stakeholders are imperative. To this end, a subsequent workshop is scheduled for May 2-3, 2024, in Rockville, Maryland, aiming to delve into the practical facets and best practices of MMFs pertinent to regulatory submissions involving modeling and simulation methodologies.
Ämnesord
- TEKNIK OCH TEKNOLOGIER -- Elektroteknik och elektronik -- Datorsystem (hsv//swe)
- ENGINEERING AND TECHNOLOGY -- Electrical Engineering, Electronic Engineering, Information Engineering -- Computer Systems (hsv//eng)
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Fang, Lanyan
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Gong, Yuqing
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Hooker, Andrew, ...
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Lukacova, Viera
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Rostami-Hodjegan ...
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Sale, Mark
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visa fler...
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Grosser, Stella
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Jereb, Rebeka
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Savic, Rada
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Peck, Carl
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Zhao, Liang
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visa färre...
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