Handbook of Analytical Quality by Design addresses the steps involved in analytical method development and validation in an effort to avoid quality crises in later stages. The AQbD approach significantly enhances method performance and robustness which are crucial during inter-laboratory studies and also affect the analytical lifecycle of the developed method. Sections cover sample preparation problems and the usefulness of the QbD concept involving Quality Risk Management (QRM), Design of Experiments (DoE) and Multivariate (MVT) Statistical Approaches to solve by optimizing the developed method, along with validation for different techniques like HPLC, UPLC, UFLC, LC-MS and electrophoresis.

This will be an ideal resource for graduate students and professionals working in the pharmaceutical industry, analytical chemistry, regulatory agencies, and those in related academic fields.

• Concise language for easy understanding of the novel and holistic concept
• Covers key aspects of analytical development and validation
• Provides a robust, flexible, operable range for an analytical method with greater excellence and regulatory compliance

• Front Cover 2
• Handbook of Analytical Quality by Design 5
• Copyright Page 6
• Contents 7
• List of Contributors 13
• About the Editors 15
• Preface 17
• 1 Introduction to analytical quality by design 21
  • 1.1 Introduction 21
  • 1.2 Analytical quality by design principles and fundamentals 22
  • 1.3 Basic analytical quality by design terminology 23
  • 1.4 Analytical quality by design strategic principles and implementation steps 23
  • 1.5 Analytical quality by design in life-cycle management 30
  • 1.6 Regulatory standpoints on analytical quality by design 31