TABLE II

Examples of Three Phase Approaches to Chemical Assessment

TriadFDA1EMEA2PQRI OINDP3BPSA4Jenke5
Material screening and selectionChemical compositionGeneral information and specificationsCompositional information, qualitative controlled extraction studyCompositional informationMaterial characterization
Simulation studyExtractablesExtraction studiesQuantitative controlled extraction studyExtractables studySystem qualification
Product assessmentOther studies as appropriateInteraction studies (migration studies)Leachables studyMigrants studySystem validation