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Springer Quality by Design in Pharmaceutical Manufacturing

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Description

Master the fundamentals of pharmaceutical development with this comprehensive monograph from Springer. Written by twenty-five experts from academia, the pharmaceutical industry, and global Pharmacopeias, this book provides a practical guide to Quality by Design (QbD) and Analytical Quality by Design (AQbD). It addresses the urgent need for implementing the QbD framework by defining essential elements such as Quality Target Product Profile (QTTP), Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), Critical Material Attributes (CMAs), and more. This text serves as a didactic resource for professionals and students looking to understand the practical applications of these frameworks in modern manufacturing and analytical development.

Key Features

Authored by twenty-five experts from academia, the pharmaceutical industry, and global Pharmacopeias.

Covers the fundamental principles and practical applications of Quality by Design (QbD) and Analytical Quality by Design (AQbD).

Explains essential development elements including Quality Target Product Profile (QTTP) and Critical Quality Attributes (CQAs).

Provides detailed definitions for Critical Process Parameters (CPPs) and Critical Material Attributes (CMAs).

Published by Springer as part of the AAPS Introductions in the Pharmaceutical Sciences series.

Product Specifications

Format
paperback
Domain
Amazon UK
Release Date
15 July 2024
Listed Since
16 July 2024

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