While these criteria were developed for toxicological testing methods, most of the principles of validation and acceptance also apply to any type of method being used to accomplish a specific objective. In this paper, I will discuss how these test method validation and acceptance criteria might be applied to the evaluation of in vitro techniques for monoclonal antibody production. Definitions When discussing new methods, it is important to understand what is meant by terms such as validation, reliability, and acceptance. Validation has been defined as the process by which the reliability and relevance of a method are established for a specific purpose. Reliability is a measure of the degree to which a method can be performed reproducibly within and among laboratories over time.
Relevance is the extent to which a method is useful for a specific purpose.
Acceptance is the process whereby a given method is determined to be suitable for a specific purpose. In order to determine the acceptability of a method, the method must have undergone adequate validation to determine the extent to which it is relevant and reliable for a specified purpose. The extent to which each criterion is met will vary with the specific method and its proposed use. The scientific rationale for the method should be provided, including a clear statement of its proposed use. The biological basis of the in vitro method and its relationship to the existing in vivo method should be explained.