|
We have witnessed how the validation process for NAMs has been steadily evolving since our founding of IIVS in 1997. At that time, validation bodies provided funding and oversite for large multi-laboratory efforts. Pre-validations were often used as a way to verify transferability of the method on a small scale to optimize and further refine the protocol, leading to greater success in larger validation studies. Then, as method developers have had to take on more of the financial burden to conduct and manage their validation efforts, they turned to ring trials to conduct their validations more quickly than the traditional pathway, sometimes with less than ideal outcomes. Now, OECD Guidance Document 34 on how to conduct validations is under review to improve and speed up the process of validations. Method developers are motivated to move their methods through the validation process themselves, whether this validation is ultimately intended to result in a test guideline for regulatory use, or if they simply want an assessment of the relevance and reliability of their method, but they may need additional support and expertise to navigate the numerous challenges in the validation process.
IIVS has participated in dozens of validations in our laboratories following both the original validation procedures and ring trials. We have experience serving as a participating laboratory, lead laboratory, member of the validation management team, peer reviewer, validation report author, and validation report and data auditor. No matter the validation paradigm, our experience in technology transfer, chemical selection, data governance, and protocol optimization is valuable to the field. The mission at IIVS is to increase the use and acceptance of non-animal testing worldwide. To further support this mission, we are offering our validation experience as a consulting service to help as many method developers as possible reach successful validation outcomes. If you would like to partner with us to provide these services or you would be interested in exploring how you could use our validation services, reach out to us via email at clientservices@iivs.org or plan to drop by our SOT booth (#1041) to talk to us. We are excited about formalizing this offering and hope to help bring your methods through the validation process successfully.
| 
