
{"id":38,"date":"2014-09-05T10:31:18","date_gmt":"2014-09-05T10:31:18","guid":{"rendered":"http:\/\/www.eurofir.org\/plantlibra\/?page_id=38"},"modified":"2015-04-20T11:06:24","modified_gmt":"2015-04-20T11:06:24","slug":"risk-and-benefit-asssessment","status":"publish","type":"page","link":"http:\/\/www.eurofir.org\/plantlibra\/science\/risk-and-benefit-asssessment\/","title":{"rendered":"Risk and benefit asssessment"},"content":{"rendered":"<p>&nbsp;<\/p>\r\n<p><a href=\"http:\/\/www.eurofir.org\/plantlibra\/wp-content\/uploads\/sites\/2\/2014\/09\/Fotolia_61732774_M.jpg\"><img loading=\"lazy\" class=\"alignright wp-image-176 \" src=\"http:\/\/www.eurofir.org\/plantlibra\/wp-content\/uploads\/sites\/2\/2014\/09\/Fotolia_61732774_M.jpg\" alt=\"Vanilla pods and orchid flower isolated on white background\" width=\"302\" height=\"201\" \/><\/a>Industry, regulators and other stakeholders are often challenged to analyse the risks as well as benefits of botanicals used in plant food supplements.<\/p>\r\n<p>PlantLIBRA developed a methodology for risk assessment that integrates compound-based information with\u00a0composition data, preparation-level evidence, and history-of-use to provide an informative evidence-based assessment, which is compatible with the methodologies proposed by authorities worldwide.<\/p>\r\n<p>Grading of evidence allows effective decision-making, and helps direct further research. Different risk assessment approaches \u2013 from the margin of exposure to the threshold of toxicological concern \u2013 are combined to maximise the information derived from datasets. Adverse events are \u00a0retrieved\u00a0systematically, using <a href=\"http:\/\/en.wikipedia.org\/wiki\/Grey_literature\">grey literature<\/a>\u00a0(when applicable) and thoroughly analysed for <a href=\"http:\/\/en.wikipedia.org\/wiki\/Causality\">causality<\/a>.<\/p>\r\n<p>PlantLIBRA risk assessments of botanicals have been\u00a0developed using\u00a0an interactive Wiki-based platform, allowing multidisciplinary work by a broad set of experts.<\/p>\r\n<p>Using ePlantLIBRA, assessments for botanicals can be rapid or in-depth. PlantLIBRA botanicals benefit assessments are based on the totality of evidence; simultaneously and rigorously addressing different regulatory thresholds from those based on human randomised clinical trials (RCT) to those used more traditionally. They also help identify and quantify data gaps.<\/p>\r\n<p><img loading=\"lazy\" class=\"alignleft wp-image-177\" src=\"http:\/\/www.eurofir.org\/plantlibra\/wp-content\/uploads\/sites\/2\/2014\/09\/Fotolia_59353287_2.jpg\" alt=\"Quinoa\" width=\"298\" height=\"197\" srcset=\"http:\/\/www.eurofir.org\/plantlibra\/wp-content\/uploads\/sites\/2\/2014\/09\/Fotolia_59353287_2.jpg 1694w, http:\/\/www.eurofir.org\/plantlibra\/wp-content\/uploads\/sites\/2\/2014\/09\/Fotolia_59353287_2-300x198.jpg 300w, http:\/\/www.eurofir.org\/plantlibra\/wp-content\/uploads\/sites\/2\/2014\/09\/Fotolia_59353287_2-1024x678.jpg 1024w\" sizes=\"(max-width: 298px) 100vw, 298px\" \/>Systematic review of the literature about\u00a0botanicals underpins risk and benefit assessments. PlantLIBRA\u2019s methodology means comprehensive reviews can be performed or updated quickly as well as providing a stand-alone service.<\/p>\r\n<p><strong><em>Case study\u00a0<\/em><\/strong><\/p>\r\n<p style=\"text-align: left\"><strong>Problem:<\/strong> there was wide concern that some botanical preparations contain genotoxic compounds, and should be banned from the market.<\/p>\r\n<p style=\"text-align: left\"><strong>ePlantLIBRA:<\/strong> we conducted an in-depth analysis of published composition data, simulated various potential\u00a0compositional combinations, and concluded the compounds of concern can be kept\u00a0at very low or non-detectable levels. It is, however, an issue that needs to be managed carefully but, in most cases, a ban was\u00a0not necessary.<\/p>\r\n<p>&nbsp;<\/p>","protected":false},"excerpt":{"rendered":"<p>&nbsp; Industry, regulators and other stakeholders are often challenged to analyse the risks as well as benefits of botanicals used in plant food supplements. PlantLIBRA developed a methodology for risk assessment that integrates compound-based information with\u00a0composition data, preparation-level evidence, and history-of-use to provide an informative evidence-based assessment, which is compatible with the methodologies proposed by [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":131,"menu_order":4,"comment_status":"closed","ping_status":"open","template":"","meta":[],"_links":{"self":[{"href":"http:\/\/www.eurofir.org\/plantlibra\/wp-json\/wp\/v2\/pages\/38"}],"collection":[{"href":"http:\/\/www.eurofir.org\/plantlibra\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"http:\/\/www.eurofir.org\/plantlibra\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"http:\/\/www.eurofir.org\/plantlibra\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"http:\/\/www.eurofir.org\/plantlibra\/wp-json\/wp\/v2\/comments?post=38"}],"version-history":[{"count":11,"href":"http:\/\/www.eurofir.org\/plantlibra\/wp-json\/wp\/v2\/pages\/38\/revisions"}],"predecessor-version":[{"id":454,"href":"http:\/\/www.eurofir.org\/plantlibra\/wp-json\/wp\/v2\/pages\/38\/revisions\/454"}],"up":[{"embeddable":true,"href":"http:\/\/www.eurofir.org\/plantlibra\/wp-json\/wp\/v2\/pages\/131"}],"wp:attachment":[{"href":"http:\/\/www.eurofir.org\/plantlibra\/wp-json\/wp\/v2\/media?parent=38"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}