Shulph Ink
Handbook of Analytical Quality by Design
Handbook of Analytical Quality by Design
- Condition: Brand new
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Excellent- More about Handbook of Analytical Quality by Design
The Handbook of Analytical Quality by Design provides a comprehensive guide to analytical method development and validation, aiming to prevent quality crises in later stages. It covers sample preparation, Quality Risk Management, Design of Experiments, Multivariate Statistical Approaches, and validation for various techniques. It is an essential resource for graduate students, professionals, and academicians in the pharmaceutical industry, analytical chemistry, regulatory agencies, and related fields.
\n Format: Paperback / softback
\n Length: 222 pages
\n Publication date: 15 January 2021
\n Publisher: Elsevier Science Publishing Co Inc
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The Handbook of Analytical Quality by Design is a comprehensive guide that delves into the intricate processes of analytical method development and validation, aimed at preventing quality crises during later stages of drug development. By adopting the AQbD approach, method performance and robustness are significantly enhanced, which are crucial for inter-laboratory studies and have a profound impact on the analytical lifecycle of the developed method. The handbook is organized into various sections, each addressing specific challenges related to sample preparation. It also explores the usefulness of the QbD concept, encompassing Quality Risk Management (QRM), Design of Experiments (DoE), and Multivariate (MVT) Statistical Approaches, to optimize the developed method and ensure its validation for various techniques such as HPLC, UPLC, UFLC, LC-MS, and electrophoresis. This resource is particularly valuable for graduate students and professionals working in the pharmaceutical industry, analytical chemistry, regulatory agencies, and related academic fields. It provides a thorough understanding of the latest advancements in analytical quality control and offers practical insights for achieving successful method development and validation.
\n Weight: 372g\n
Dimension: 154 x 228 x 18 (mm)\n
ISBN-13: 9780128203323\n \n
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