Walidacja metod analitycznych

Name: Walidacja metod analitycznych
Brand: Wydawnictwo Nasza Wiedza
SKU: 9786630025309
Price: 5111.0 INR
Availability: InStock

by Faiza Bouchala , Sabah Benboudiaf

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ISBN13: 9786630025309
Binding: Paperback
Subject: N/A
Publisher: Wydawnictwo Nasza Wiedza
Publisher Imprint: Wydawnictwo Nasza Wiedza
Publication Date: June 4, 2026
Pages: 52
Original Price: USD 57.0
Language: Polish
Edition: N/A
Item Weight: 82 grams
BISAC Subject(s): Pharmacology

About The Book

Niniejszy przewodnik oferuje rygorystyczne i zaktualizowane spojrzenie na dyscyplinę leżącą w samym sercu nauk analitycznych. Najpierw przedstawia krytyczny przegląd gl�wnych obowiązujących wytycznych międzynarodowych - ICH Q2(R2), ICH Q14, ICH M10, FDA, EMA, SFSTP, Eurachem, IUPAC, COFRAC, AOAC i SANTE - analizując dla każdej z nich przyjęte kryteria, zalecane plany eksperymentalne, mocne strony i ograniczenia. Następnie, z terminologiczną rygorystycznością wymaganą przez Międzynarodowy Slownik Metrologii, bada wszystkie kryteria walidacji: specyficznośc, selektywnośc, liniowośc, precyzję, poprawnośc, dokladnośc, granice wykrywalności i oznaczalności oraz odpornośc. Na koniec przedstawia profil dokladności, zintegrowane narzędzie decyzyjne oparte na koncepcji blędu calkowitego oraz przedzialach tolerancji $\beta$-oczekiwania, kt�re po raz pierwszy pozwala na jednoczesną i globalną ocenę wszystkich źr�del blęd�w w calym zakresie analitycznym - oraz na wyciągnięcie z niej jasnej, wizualnej i możliwej do obrony przed każdym organem regulacyjnym decyzji o walidacji.

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