“Has this method been validated?” “Can you help validate our test?”
At IIVS, we are often asked these and similar questions for a variety of reasons. Sometimes clients would like to know whether a certain in vitro protocol has been validated (is it reproducible and reliable) and will it meet their testing goals. Sometimes they inquire if it is validated for regulatory use. Other times they would like assistance in validating a protocol to screen their unique product candidates. We are also frequently called upon by industry consortia and methods developers to participate in or lead a formal multi-laboratory validation of methods for potential regulatory use. What is assay validation, and what are the goals of a validation? Validation is a planned, detailed, fully documented process for the experimental and statistical evaluation of a proposed method, including the associated prediction model, within the constraints of its intended purpose. Simply put: Does the method do what it is intended to do? Please read the attached article for additional information.