The Role of Prevalidation in the Development, Validation and Acceptance of Alternative Methods
The outcome of large and expensive validation studies on alternative methods can be compromised if their managers do not insist that optimised test protocols and proof of their performance are submitted before the start of the formal validation study. A prevalidation study would involve the developers and selected independent laboratories in protocol refinement (Phase I) and protocol transfer (Phase II). The optimised protocol would then be assessment in a protocol performance phase (Phase III), which would involve the testing of a relevant set of coded test materials and an evaluation of a proposed prediction model. The European Centre for the Validation of Alternative Methods (ECVAM) proposes to introduce this prevalidation scheme into its validation strategy.
Bibliographic Reference: Article: Alternatives to Laboratory Animals, Vol. 23 (1995) pp. 211-217
Record Number: 199610369 / Last updated on: 1996-04-15
Original language: en
Available languages: en