1. MPA requirements on validation of bioanalytical methods The analytical method should be validated before analysing of specimens from GLP and GCP studies are done. The validation should be reported as a validation report. It should be possible to verify reported data in the validation report against raw data. Maintenance and calibration of the equipment used during the conduct of the validation study should be documented.

2. General requirements for validation of analytical methods Precision - Repeatability - Intermediate precision - Reproducibility Accuracy Limit of Quantification, LOQ Limit of Detection, LOD Specificity Linearity Range Robustness System suitability

3. Requirements for Bioavailability and Bioequivalence studies CPMP/EWP/QWP/1401/98, dated 26 July 2001 Date for coming into operation January 2002.

4. MPA does not expect validation studies for bioanalytical methods to be formal GLP studies