ALTERNATIVES FOR SKIN SENSITIZATION （替代皮肤敏化）.pdf

CASE STUDY 5 L’OREAL APPROACH DECISION STRATEGY ALTERNATIVES FOR SKIN SENSITIZATION TESTING Joint Cefic/ Cosmetics Europe/EPAA Workshop HELSINKI, 23-24 APRIL 2015 Silvia Teissier / Nathalie Alépée ADVANCED RESEARCH CRITERIAAND NEEDS FOR AN IDEAL INDUSTRY-APPLICABLE ITS  Based on robust/reliable data  Validated assays (internally and/or formally evaluated)  Mechanistic-based  Integrating data from different key events  Well defined Predictive Models  Comprehensive and statistically validated (learning sets ≠ validation sets / avoid statistical bias through unbalanced sets)  Prediction with confidence indication  Probability of S/NS  Has to be « toxicologist-/ user friendly », not dependent on particular / subjective expertise or interpretations  Applicable to the wide physicochem. diversity of cosmetic ingredients  Accessible assay (Availability/Cost/Time…) DIFFERENT APPROCHES TO BUILD SUCH AN ITS Selection of Approach to build Input Methods / Input Data Prediction models Parameters Choice for a Gold Standards A priori selection References particular approach