Chapter 4. Statistical Considerations in Analytical Method Validation

Bruno Boulanger^[]

^[] Bruno Boulanger is Manager, European Early Phase Statistics, Eli Lilly and Company, Belgium.

Viswanath Devanaryan ^[]

^[] Viswanath Devanaryan is Associate Director, Biostatistics and Research Decision Sciences, Merck, USA.

Walthère Dewé ^[]

^[] Walthère Dewée is Senior Research Scientist, Global Discovery and Development Statistics, Eli Lilly and Company, Belgium.

Wendell Smith ^[]

^[] Wendell Smith is Partner and Senior Statistician, Bowsher Brunelle Smith (B2S Consulting), USA.

In the context of a pre-study validation of an analytical method, this chapter describes some advanced statistical methodologies available in the literature and provides SAS code to calculate the validation criteria. Both linear and non-linear methods are described within the calibration framework. In terms of validation criteria, i.e., when the calculated concentrations are available, criteria based on measurement error are utilized and useful graphical representations are proposed.