50,00 €*
Versandkostenfrei per Post / DHL
Aktuell nicht verfügbar
Key features: Full review of the available regulatory guidelines on validation and in particular, ICH. Sections of the guideline, Q2(R1), have been reproduced in this book with the kind permission of the ICH Secretariat; Thorough discussion of each of the validation characteristics (Specificity; Linearity; Range; Accuracy; Precision; Detection Limit; Quantitation Limit; Robustness; System Suitability) plus practical tips on how they may be studied; What to include in a validation protocol with advice on the experimental procedure to follow and selection of appropriate acceptance criteria; How to interpret and calculate the results of a validation study including the use of suitable statistical calculations; A fully explained case study demonstrating how to plan a validation study, what to include in the protocol, experiments to perform, setting acceptance criteria, interpretation of the results and reporting the study.
Key features: Full review of the available regulatory guidelines on validation and in particular, ICH. Sections of the guideline, Q2(R1), have been reproduced in this book with the kind permission of the ICH Secretariat; Thorough discussion of each of the validation characteristics (Specificity; Linearity; Range; Accuracy; Precision; Detection Limit; Quantitation Limit; Robustness; System Suitability) plus practical tips on how they may be studied; What to include in a validation protocol with advice on the experimental procedure to follow and selection of appropriate acceptance criteria; How to interpret and calculate the results of a validation study including the use of suitable statistical calculations; A fully explained case study demonstrating how to plan a validation study, what to include in the protocol, experiments to perform, setting acceptance criteria, interpretation of the results and reporting the study.
| Erscheinungsjahr: | 2009 |
|---|---|
| Genre: | Importe, Technik allg. |
| Rubrik: | Naturwissenschaften & Technik |
| Medium: | Taschenbuch |
| ISBN-13: | 9780956152817 |
| ISBN-10: | 0956152813 |
| Sprache: | Englisch |
| Ausstattung / Beilage: | Paperback |
| Einband: | Kartoniert / Broschiert |
| Autor: | McPolin, Oona |
| Hersteller: | Mourne Training Services |
| Verantwortliche Person für die EU: | Books on Demand GmbH, In de Tarpen 42, D-22848 Norderstedt, info@bod.de |
| Maße: | 297 x 210 x 9 mm |
| Von/Mit: | Oona McPolin |
| Erscheinungsdatum: | 05.05.2009 |
| Gewicht: | 0,414 kg |
| Erscheinungsjahr: | 2009 |
|---|---|
| Genre: | Importe, Technik allg. |
| Rubrik: | Naturwissenschaften & Technik |
| Medium: | Taschenbuch |
| ISBN-13: | 9780956152817 |
| ISBN-10: | 0956152813 |
| Sprache: | Englisch |
| Ausstattung / Beilage: | Paperback |
| Einband: | Kartoniert / Broschiert |
| Autor: | McPolin, Oona |
| Hersteller: | Mourne Training Services |
| Verantwortliche Person für die EU: | Books on Demand GmbH, In de Tarpen 42, D-22848 Norderstedt, info@bod.de |
| Maße: | 297 x 210 x 9 mm |
| Von/Mit: | Oona McPolin |
| Erscheinungsdatum: | 05.05.2009 |
| Gewicht: | 0,414 kg |
Ähnliche Produkte
Lieferzeit 4-7 Werktage
Lieferzeit 2-3 Wochen
Lieferzeit 1-2 Wochen
Lieferzeit 4-7 Werktage
Lieferzeit 2-3 Wochen
