An essential requirement of the validation process is that each stage of the specification, design, construction, installation, testing and maintenance of a containment system should be clearly documented.
Since the results did not change, and the requirement of CAGE validation of TSSs reduced the size of our data-set significantly, we did not use the CAGE validated TSSs further.
This, in turn, underscores the requirement of experimental validation tools including quantitative reverse transcription polymerase chain reaction (qRT-PCR) and western blot analyses to indicate the functional miRNA and MMIs.
The exclusion criteria were publication in a language other than English, appearance of the word "validation" only in the references, no mention of the validation method for numerical FEA analysis, and mentioning of the requirement for validation without conduction of the actual validation.
Validation was performed within the requirements of ICH validation guidelines (Q2A, Q2B and Q3C) and based on Good Laboratory Practices (GLP).
A priori criteria of consensus for validation for each of the indicators were defined; an average score of 70% or greater agreement by the expert panellists, across all four elements of preventability for each indicator, were deemed to meet requirements for validation of an indicator.
Corvi et al. (2006) suggested requirements for validation of transcriptomics in regulatory toxicology, but it is unlikely that this validation process will be rapid.
The literature is replete with transient indications of biomarker significance, such that the requirement for validation is now the norm.
Our Aversi_ITS showed also to be repeatable, with a RSD r, for all dilutions above the LOD, lower than 25%%, thereby fulfilling the requirements of the validation guidelines used in this study.
This short response time has proved critical as the types of data provided and requirements for validation have changed over the course of the project.
