Bioanalytical Method Validation

Bioanalytical Method Validation is the focus of this chapter. Validation procedures for chromatographic, immunological and microbiological assays are described. The final reports of the 1990 and 2000 Washington Conferences and the US FDA 2001 Guidance for the Industry on "Bioanalytical Methods Validation" are discussed with specific emphasis on the use of advanced hyphenated techniques and automated sample processing. Current validation practice is examined, including method selectivity, precision and accuracy. Common problems and solution during validation involving selectivity vs. specificity, reference standard, calibration curve, rejection of calibration standard, ±15/20% criteria, internal standard, dilutions, recovery, carry-over, system suitability test, stability and stereoisomer assays are addressed and discussed. The Universal Bioanalytical Method theory, based on the development and validation of a plasma matrix independent method, is introduced. The chapter contains 27 references.