ISBN: 9786630015065 - validation of analytical methods: approaches, criteria and accuracy profile reference manual for pharmaceutical and analytical sciences (8 risultati)

Paperback or Softback. Condizione: New. Validation of analytical methods. Book.

Condizione: New.

PAP. Condizione: New. New Book. Shipped from UK. THIS BOOK IS PRINTED ON DEMAND. Established seller since 2000.

PAP. Condizione: New. New Book. Delivered from our UK warehouse in 4 to 14 business days. THIS BOOK IS PRINTED ON DEMAND. Established seller since 2000.

Taschenbuch. Condizione: Neu. This item is printed on demand - it takes 3-4 days longer - Neuware 52 pp. Englisch.

Taschenbuch. Condizione: Neu. nach der Bestellung gedruckt Neuware - Printed after ordering - 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 beta-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. …

Paperback. Condizione: new. Paperback. 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 b-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. This item is printed on demand. Shipping may be from our UK warehouse or from our Australian or US warehouses, depending on stock availability. …

Taschenbuch. Condizione: Neu. This item is printed on demand - Print on Demand Titel. Neuware 52 pp. Englisch.