Difference between revisions of "Benefit-risk assessment of food supplements"
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A review of the concepts of validation and fit-for-purpose in the field of risk, benefit and risk- | A review of the concepts of validation and fit-for-purpose in the field of risk, benefit and risk- |
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Risk-benefit assessment for food supplements is a method about making assessments for plant-based food supplements (PFS).[1]
This page is a Plantlibra deliverable (see all). <section begin=plantlibra />
- Name: DWP5-1 Risk-benefit methodologies
- Responsible partner: THL, Jouni
- Deadline: June 2011
- Status: Scoping started
<section end=plantlibra />
Scope
What is a good method for making benefit-risk assessments for plant-based food supplements? How is the method validated?
Definition
Based on findings reported in the review (DWP5-1) and a preliminary conceptual workshop held
at the kick-off meeting (MWP5-1), a risk-benefit assessment methodology will be proposed and
tested in selected case-studies. The methodology, to be developed in Opasnet, should be
organized in tiers, allowing to identify risk-benefit scenarios and to address qualitatively
scenarios (e.g., through MOE, ADI) where risks or benefits are not overlapping. After
preliminary testing of the methodology on at least 5 case-studies drawn from the PlantLIBRA
list of case-studies, the report will be submitted for review to partners and to the three
advisory boards; their feedback will be discussed, aligned with outcomes of WP2 (benefits,
specifically definition of benefits and integration of various types of evidence), WP3 (risks and
new approaches for risk assessment) and WP4 (acute risks, specifically epidemiological
evidence), and integrated at the second project meeting. Uncertainty will be described and
estimated when possible. The final report will be published alongside with a generic Analytica
software tool to explore risk and benefits (DWP5-1).
Task leader: THL
PM: THL 5, Hylo 3, UMIL 0.5
A review of the concepts of validation and fit-for-purpose in the field of risk, benefit and risk-
benefit assessment will be conducted by Hylo in peer-reviewed literature and reported (DWP5-
1). Following review by partners and advisory boards, a protocol with requirements to assess
fit-for-purpose and to validate (potentially against unused data-sets) the different assessment
methodologies will be prepared using the Opasnet platform and reported by THL (MWP5-2).
Task leader: THL
PM: THL 6, Hylo 3
Result
Suggested methods:
- Margin of exposure (MOE)
- Acceptable daily intake (ADI)
- Quantitative benefit-risk assessment
See also
References
- ↑ The research leading to these results has received funding from the European Union Seventh Framework Programme under grant agreement number 245199.
Related files
<mfanonymousfilelist></mfanonymousfilelist>