Bioequivalence and Bioavailability Forum

Dear Constantinos
the Guideline on bioanalytical method validation EMEA/CHMP/EWP/192217/2009 states in paragraph 4.2. Partial validation: "In situations where minor changes are made to an analytical method that has already been validated, a full validation may not be necessary, depending on the nature of the applied changes. Changes for which a partial validation may be needed include transfer of the bioanalytical method to another laboratory, change in equipment, calibration concentration range, limited sample volume, another matrix or species, change in anticoagulant, sample processing procedure, storage conditions etc. All modifications should be reported and the scope of revalidation or partial validation justified.
Partial validation can range from as little as the determination of the within-run precision and accuracy, to an almost full validation."
I hope this helps
Kind regards
Dan