Implementation of New Test Methods into Practical Testing

Abstract

New toxicology test methods, especially those using in vitro methods, are continually being developed. Some are used by industry for screening purposes; others are eventually validated for regulatory use. However, for a new test method to be firmly adopted by industry it must be readily available, generally through an in-house industry laboratory, an academic laboratory, or a contract research organization. Regardless of the type of laboratory which intends to implement the test method, certain steps must be taken to ascertain that the method that is put into place is reproducible and performs identically to the test method that was published or has undergone validation. This involves developing protocols and standard operating procedures, training staff, developing historic positive and negative control data, establishing acceptable performance with proficiency chemicals, and addressing all the safety concerns that may accompany the assay. From experience within a contract research laboratory, we provide guidance on how to most efficiently accomplish these tasks.