Benefit-risk assessment of food supplements

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Risk-benefit assessment for food supplements is a method about making assessments for plant-based food supplements (PFS).

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

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Scope

What is a good method for making benefit-risk assessments for plant-based food supplements? How is the method validated?

Definition

TODO: {{#todo:Task 5.2 (Month 1-14): Tiered methodology for risk benefit assessment|Jouni|Plantlibra}}


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

TODO: {{#todo:Task 5.3 (Month 1-14): Methodology for validation of risk, benefit and risk-benefit assessment |Jouni|Plantlibra}}


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:

See also

References


Related files

<mfanonymousfilelist></mfanonymousfilelist>

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