Name: Method Validation in Pharmaceutical Analysis: A Guide to Best Practice (en Inglés)
Price: 190080.00 CLP
Availability: InStock
Author: Ermer, Joachim ; Nethercote, Phil W.
ISBN: 9783527335633

portada Method Validation in Pharmaceutical Analysis: A Guide to Best Practice (en Inglés)

Formato

Libro Físico

Ilustrado por

Joachim Ermer

Phil W. Nethercote

Editorial

Wiley-Vch

Autor

Ermer, Joachim ; Nethercote, Phil W.

Idioma

Inglés

Encuadernación

Tapa Dura

Dimensiones

24.1 x 17.5 x 3.0 cm

Peso

0.86 kg.

ISBN13

9783527335633

N° edición

0002

Categorías

Farmacología
Farmacia y prescripción

Method Validation in Pharmaceutical Analysis: A Guide to Best Practice (en Inglés)

Joachim Ermer (Ilustrado por) · Phil W. Nethercote (Ilustrado por) · Wiley-Vch · Tapa Dura

Libro Físico

$ 190.080

$ 316.800

Ahorras: $ 126.720

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Reseña del libro "Method Validation in Pharmaceutical Analysis: A Guide to Best Practice (en Inglés)"

This second edition of a global bestseller has been completely redesigned and extensively rewritten to take into account the new Quality by Design (QbD) and lifecycle concepts in pharmaceutical manufacturing. As in the first edition, the fundamental requirements for analytical method validation are covered, but the second edition describes how these are applied systematically throughout the entire analytical lifecycle. QbD principles require adoption of a systematic approach to development and validation that begin with predefined objectives. For analytical methods these predefined objectives are established as an Analytical Target Profile (ATP). The book chapters are aligned with recently introduced standards and guidelines for manufacturing processes validation and follow the three stages of the analytical lifecycle: Method Design, Method Performance Qualification, and Continued Method Performance Verification. Case studies and examples from the pharmaceutical industry illustrate the concepts and guidelines presented, and the standards and regulations from the US (FDA), European (EMA) and global (ICH) regulatory authorities are considered throughout. The undisputed gold standard in the field.