| Literature DB >> 32625631 |
Anthony Hardy, Diane Benford, Thorhallur Halldorsson, Michael John Jeger, Helle Katrine Knutsen, Simon More, Hanspeter Naegeli, Hubert Noteborn, Colin Ockleford, Antonia Ricci, Guido Rychen, Josef R Schlatter, Vittorio Silano, Roland Solecki, Dominique Turck, Maged Younes, Jean-Louis Bresson, John Griffin, Susanne Hougaard Benekou, Henk van Loveren, Robert Luttik, Antoine Messean, André Penninks, Giuseppe Ru, Jan Arend Stegeman, Wopke van der Werf, Johannes Westendorf, Rudolf Antonius Woutersen, Fulvio Barizzone, Bernard Bottex, Anna Lanzoni, Nikolaos Georgiadis, Jan Alexander.
Abstract
EFSA requested its Scientific Committee to prepare a guidance document providing generic issues and criteria to consider biological relevance, particularly when deciding on whether an observed effect is of biological relevance, i.e. is adverse (or shows a beneficial health effect) or not. The guidance document provides a general framework for establishing the biological relevance of observations at various stages of the assessment. Biological relevance is considered at three main stages related to the process of dealing with evidence: Development of the assessment strategy. In this context, specification of agents, effects, subjects and conditions in relation to the assessment question(s): Collection and extraction of data; Appraisal and integration of the relevance of the agents, subjects, effects and conditions, i.e. reviewing dimensions of biological relevance for each data set. A decision tree is developed to assist in the collection, identification and appraisal of relevant data for a given specific assessment question to be answered.Entities:
Keywords: adverse effect; beneficial effect; biological relevance; nature of the effect; scientific assessment; size of the effect
Year: 2017 PMID： 32625631 PMCID： PMC7010076 DOI： 10.2903/j.efsa.2017.4970
Source DB: PubMed Journal: EFSA J ISSN： 1831-4732