Is the bioanalytical community ready to revise the use of certain validation concepts and nomenclature? 


“Having a harmonized definition of what defines a method and with the differentiation of the validation experiments, we believe it is possible to improve clarity in the regulatory requirements…” For more than 10 years the US FDA Guidance on Bioanalytical Method Validation [101] has provided a common foundation for bioanalytical scientists. The general validation process along with concepts and nomenclature has been broadly adopted by the bioanalytical community even though specific scientific issues have been, and are still debated.  However, in light of the recently published European Medicines Agency (EMA) Guideline on Bioanalytical Method Validation [102] and the ongoing process...

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