Considerations In The Development Of In Vitro Toxicity Testing Methods Intended For Regulatory Use

It has been demonstrated that the performance of in vitro toxicity testing methods can be seriously affected by variability in the essential components of the method, including the experimental protocol, the test items (chemicals), the test system (the biological models), and the analytical or measurement technique(s) used. Therefore, these aspects need careful consideration during the development of in vitro methods if they are to be used in regulatory applications where compliance with quality systems is typically a prerequisite. Concerning the test system, implementation of the basic concepts of Good Cell Culture Practices (GCCP) is essential in the identification and characterization of the biological model (test system part of the in vitro method). An adequate quality system, preferably Good Laboratory Practice (GLP) together with GCCP leads to overall Good In vitro Method Practices (GIVIM). Additional guidance for test developers will help to ensure that in vitro methods destined for regulatory use will prove to be robust, reliable, and ultimately useful for supporting regulatory decisions.