The value of in silico methods in drug development and evaluation has been demonstrated repeatedly and convincingly. While their benefits are now unanimously recognized, international standards for their evaluation, accepted by all stakeholders involved, are still to be established.In this white paper, we propose a risk-informed evaluation framework for mechanistic model credibility evaluation. To properly frame the proposed verification and validation activities, concepts such as context of use, regulatory impact and risk-based analysis are discussed. To ensure common understanding between all stakeholders, an overview is provided of relevant in silico terminology used throughout this paper.To illustrate the feasibility of the proposed approach, we have applied it to three real case examples in the context of drug development, using a credibility matrix currently being tested as a quick-start tool by
Accepted ArticleThis article is protected by copyright. All rights reserved regulators. Altogether, this white paper provides a practical approach to model evaluation, applicable in both scientific and regulatory evaluation contexts.
SummarySince the resources available for nature conservation tend to be very limited, localised conservation actions are often the only feasible management option. Therefore, we must select key areas where these actions will be most effective. Here we used Weighted Linear Combination (WLC) to integrate various variables in a GIS environment and identify key areas for implementing conservation actions benefiting Cinereous Vultures Aegypius monachusin south-east Portugal. Through a bibliographic search, we selected four main variables and sub-variables related to land use, food availability, disturbance and topography. These were weighted for their relative importance using the Analytic Hierarchy Process (AHP) and combined using WLC to obtain suitability maps for the best nesting and foraging sites for Cinereous Vultures. Overall, the study areas show moderate to high suitability as foraging areas for the species, but only a few small patches seem suitable as nesting sites. The use of GIS-based decision support systems, such as WLC, together with an objective method for weighting variables, like the AHP, allows for the integration of large amounts of cartographic information into suitability maps that can easily be used to select key areas for conservation at the regional level.
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