Performance Standards for the Human Recombinant Estrogen Receptor Binding Assay

This document is intended as a guide to developers of new test methods that are analogous to existing, fully validated test methods in that they are based on similar scientific principles and predict the same effect(colloquially referred to as “me too” tests) .This document contains the Performance Standards (PS) for the human recombinant estrogen receptor (hrER) binding assay. These PS accompany the Performance-Based Test Guideline (PBTG) for human recombinant estrogen receptor in vitro assays to detect chemicals with ER binding affinity (TG 493). The PS are intended for the developers of new or modified test methods, similar to the validated reference methods.