Handbook of Analytical Quality by Design
  • Release Date : 09 January 2021
  • Publisher : Academic Press
  • Genre : Business & Economics
  • Pages : 222 pages
  • ISBN 13 : 9780128203330
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Download or read book entitled Handbook of Analytical Quality by Design by author: Sarwar Beg which was release on 09 January 2021 and published by Academic Press with total page 222 pages . This book available in PDF, EPUB and Kindle Format. 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