The use of test method performance standards to streamline the validation process

WS Stokes¹, LM Schechtman², ML Wind³, A Rispin⁴, K Gupta⁵, RR Tice⁶

1. NICEATM, RTP, NC, USA
2. U.S. FDA, NCTR, Rockville, MD, USA
3. U.S. CPSC, Directorate for Health Sciences, Bethesda, MD, USA
4. U.S. EPA, Bethesda, MD, USA
5. U.S. CPSC, Bethesda, MD, USA
6. ILS, Inc., RTP, NC, USA

Regulatory authorities are often required to communicate the basis on which new test methods have been determined to have sufficient accuracy and reliability for specific testing purposes. The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) recently developed the concept of test method performance standards (PS) to address this need. PS are based on adequately validated proprietary and nonproprietary test methods that have been accepted by one or more regulatory agencies. PS can then be used to evaluate the performance of other mechanistically and functionally similar test methods that measure or predict the same biological or toxic effect. PS consist of three aspects:

1. essential test method components, which are the essential structural, functional, and procedural elements of a validated test method that should be included in the protocol of a proposed similar test method);
2. a minimum list of reference chemicals selected from the chemicals used to demonstrate acceptable performance of the validated test method, which is used to assess the accuracy and reliability of a proposed similar test method; and
3. the accuracy and reliability values that should be achieved or exceeded by the proposed test method when evaluated using the minimum list of reference chemicals.

Proposed PS are developed and undergo concurrent independent peer review during the technical evaluation of a test method. The development and use of PS is expected to significantly streamline the validation and acceptance process for test methods that are mechanistically and functionally similar to accepted test methods.

Date: Wednesday, August 24, 2005, 14.00-16.00 h, Estrel Hall A

5.13 Workshop: Strategies for Priorotizing and Streamlining the Validation Process