Validation of analytical methods: Approaches, criteria and accuracy profile Reference manual for pharmaceutical sciences

This guide offers a rigorous, up-to-date exploration of a discipline at the heart of the analytical sciences. It begins with a critical overview of the main international standards in force - ICH Q2(R2), ICH Q14, ICH M10, FDA, EMA, SFSTP, Eurachem, IUPAC, COFRAC, AOAC and SANTE - analyzing for each the criteria adopted, the recommended experimental designs, the strengths and limitations. It then examines, with the rigorous terminology required by the International Vocabulary of Metrology, all the validation criteria: specificity, selectivity, linearity, precision, accuracy, limits of quantification and detection, robustness. Finally, it presents the accuracy profile, an integrated decision-making tool based on the concept of total error and ß-expectation tolerance intervals, which for the first time makes it possible to assess all sources of error simultaneously and globally across the entire analytical field - and to derive a clear, visual validation decision that can be defended before any regulatory authority.

Pagina's: 52, Paperback, Our Knowledge Publishing