Mastering Analytical Quality by Design: A Comprehensive Handbook

Authored by renowned expert Sarwar Beg, the Handbook of Analytical Quality by Design is an indispensable resource for professionals and graduate students in the pharmaceutical industry, analytical chemistry, regulatory agencies, and related academic fields.

Addressing Quality Crises with AQbD Approach

The Handbook delves into the crucial steps involved in analytical method development and validation, ensuring that quality crises are mitigated in later stages. By adopting the Analytical Quality by Design (AQbD) approach, method performance and robustness are significantly enhanced, making it an essential strategy for inter-laboratory studies and the analytical lifecycle of developed methods.

Comprehensive Coverage of Key Topics

The Handbook provides in-depth coverage of:

• Sample preparation problems and their solutions using the QbD concept
• Quality Risk Management (QRM) and Design of Experiments (DoE) for optimal method development
• Multivariate (MVT) Statistical Approaches for method validation
• Validation techniques for HPLC, UPLC, UFLC, LC-MS, and electrophoresis

This comprehensive resource is designed to facilitate easy understanding of the novel and holistic concept of Analytical Quality by Design, making it an ideal companion for professionals and students seeking to excel in the field.

Key Benefits and Features

The Handbook offers:

• Concise language for easy comprehension
• Covers key aspects of analytical development and validation
• Provides a robust, flexible, and operable range for analytical methods with greater excellence and regulatory compliance

Publication Details:
Publisher: Elsevier Science
Publication Date: January 9, 2021
Language: English
ISBN: 9780128203323, 9780128203330