The guidelines set forth in the FDA Guidance provide the framework that can be applied to most cases of analytical method validation, regardless of the analytical principle employed, and is most likely to assure the necessary reliability of an analytical method. However, it is understood that there are situations and methodologies where a validation cannot produce the degree of accuracy or precision described. The over-riding question that needs to be addressed by the bioanalyst is whether the analytical method reliably meets the need(s) of the clinical study. In these cases, if the bioanalyst has demonstrated due diligence and effort in method development, and the reliability of assay given the requirements of the study, validations with lower standards may also be deemed acceptable.
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