The validation was performed according to the International Conference on Harmonization Guidance for the Validation of Analytical Methods (Guideline, ICH Harmonized Tripartite 2005).
These elements are consistent with recent regulatory guidance for systems validation.
The statistical results and biological analysis of these genes from this work might further help understand different human cancer types and provide guidance for related validation experiments.
The only current related regulatory guidance is the bioanalytical guidance for method validation.
Regulatory guidance for the validation of analytical procedures has been developed for drug product/formulation testing; however, verification of the formulation concentrations falls under the framework of GLP regulations (not GMP).
This suggests that some of these antibodies are staining the cells in an unspecific manner (false positives) and the RNA data can thus provide guidance for the validation of the corresponding antibodies.
Within the NTR, the Validation/Clinical Studies Core seeks to identify and provide guidance for the validation needs of the participating investigators, and in so doing, establish best practices for other investigators to use in their efforts to validate the combination of medical imaging devices and their companion biomarkers.
The increased interest and application of chemical screening methods based on chromatography and MS has resulted in a need for more detailed and harmonized guidance and criteria for validation of such methods [ 29, 30].
Despite of known informatics constrains, such as, model overfitting and limitations in the employed functional assays the results suggest that comparative analyses for defining conserved repressor elements is a valid approach providing efficient guidance for the experimental validation.
