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Tiered Testing Approaches

In spite of intensive effort over the last twenty years, only a few in vitro assays for acute endpoints are internationally accepted as validated. However, many industrial organizations use multiple in vitro assays on a daily basis to make safety and efficacy decisions. Industry has confidence in this approach because they have assessed the performance of in vitro assays on a small, well-defined range of products of similar chemistry. We encourage this strategy and help many companies implement their own highly beneficial in vitro testing programs.

Due to the increasing pressures compelling industry towards the use of non-animal methods, a larger number of assays for a broad range of toxicity endpoints will be required. To insure that these methods are predictive and reliable they must undergo validation. IIVS has been chosen to participate in dozens of national and international validation studies often as the lead laboratory. Through this experience we understand the key factors influencing the speed of validation and regulatory acceptance of in vitro assays such as:

  • Availability of human correlation data
  • Reliable and relevant animal data correlated to the human response
  • Strict laboratory compliance with protocols
  • Significant expense and time required to complete multi-phase validation studies

Our extensive experience and knowledge of the validation process is available to you. We can help your company or consortium by organizing a specific validation program that meets your needs.

Prevalidation and Validation

IIVS has experience in managing programs for optimization of assay systems of specific interest to your company or organization, and in managing prevalidation and validation projects for groups of companies interested in bringing a system forward for regulatory acceptance. IIVS can be an active participant serving as the lead laboratory, providing the technology transfer, training, and standardized documentation (SOP and Protocol generation) for multi-laboratory projects. IIVS can prepare or assist in the preparation of data packages for submission either to ICCVAM or directly to a regulatory agency.