Statistical analysis and endpoint derivation

• Re-evaluation of full historical data packages to derive overall endpoints including Tier I to Tier III studies (single or multiple mesocosm), including review of methods for meaningful outcomes
• Derivation of ECx values (e.g., EC10, EC20) and no observed effect concentration (NOEC) for investigations performed by CEA or by 3rd parties (historical studies) to address regulatory requirements
• Minimal detectable difference (MDD) analysis of CEA or historical mesocosm datasets to meet the requirements of EFSA aquatic guidance (2013)
• Deriving predicted no effect concentrations (PNECs) and Environmental Quality Standards (EQS)
• Multivariate statistics, e.g., principal component analyses (PCA) and principal response curve (PRC)
• Ecorelevant endpoints for wild mammals, including bench mark dose (BMD) modelling

Examples of past statistical analysis projects delivered by CEA

• EC10/20 calculations for third party studies on bird, fish, invertebrate, algae, etc., for an insecticide, as requested by the regulatory authority at active substance renewal
• MDD analysis for a mesocosm study performed at CEA on a herbicidal active substance
• MDD analysis for three historical mesocosm studies performed by third parties, as requested by regulatory authority at active substance renewal
• Review of statistical methodology used for mesocosm study and corresponding MDD analysis
• Review of historical Daphnia magna reproduction investigation to address suitability of experimental methods and their impact on the statistical analysis, including derivation of new endpoints (ECx, NOEC)