The applicability of this regulatory pathway in clinical practice has focused on overcoming drug resistance to chemotherapy [ 10, 11] or controlling mesangial inflammation [ 12], but it has not been considered in the light of chronic kidney disease so far.
Some regulatory bodies may have internal peer-review processes, specific regulatory mandates, and/or regulatory assessment procedures that also have a role in the determination of test method applicability in regulatory programs, even though a test method may have been appropriately validated.
However, a great deal of interest exists for the further development of in vitro based toxicogenomics methods, for an examination of their potential applicability in the regulatory arena, and for an appraisal of their potential for contributing to improvements in animal welfare.
While this would lower the influence of subjectivity somewhat, it would also lower the flexibility and regulatory applicability of these kinds of assessment schemes.
Regulators wish to be involved and discuss regulatory applicability of such initiatives (see also BOS1 paper).
Experience in the validation of conventional alternative test methods has led to an understanding that new and innovative approaches likely will be necessary to standardize test methods based on toxicogenomics and to evaluate the scientific validity and regulatory applicability of such test methods.
Similarly, the applicability of information regarding genome wide regulatory events will likely be greatest between closely related species.
Regulators encourage such academic industry initiatives and are amenable to discuss the applicability of the resulting models/datasets in regulatory submissions.
Work by Babu's group [ 6- 8] on the evolution of regulatory networks in E. coli and S. cerevisiae has demonstrated the applicability of such approaches to regulatory networks.
Although the input lists are developed from the perspective of regulatory and research needs of the U.S. EPA, we believe that our overall conclusions will have wide applicability.
At this meeting experts from science, industry and regulatory bodies discussed the applicability of OECD test guidelines (TGs) for chemicals to nanomaterials.
