Publication / Source: Bioanalysis 4(14)
Authors: Olsson OA, Liljeblad M, Nilsson BL, Silvester S
“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  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.