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.
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.
Płać wygodnie kartą, Klarną, Apple Pay lub Google Pay. Nie jesteś zadowolony? Zawsze masz 14-dniową gwarancję zwrotu pieniędzy. Więcej przeczytasz w naszych warunkach. Masz pytania? Napisz do nas na hello@memmo.org.
Memmo ułatwia naukę – gdziekolwiek jesteś na świecie. U nas znajdziesz podręczniki i sprytne narzędzia do nauki w jednym miejscu: streszczenia, quizy, podcasty i fiszki. A do tego Ted, Twój kumpel do nauki, który odpowie na wszystko, co Cię nurtuje. Ponad 50 000 studentów już tu się uczy – stworzone, byś uczył się szybciej i mniej stresował.