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.
1. Chapter 1. Introduction to analytical quality by design - p. 1 2. Chapter 2. Analytical quality by design for spectrophotometric method development - p. 15 3. Chapter 3. Analytical quality by design for gas chromatographic method development - p. 45 4. Chapter 4. Analytical quality by design for size-exclusion chromatography - p. 71 5. Chapter 5. Analytical quality by design for liquid chromatographic method development - p. 87 6. Chapter 6. Analytical quality by design for high-performance thin-layer chromatography method development - p. 99 7. Chapter 7. Analytical quality by design for capillary electrophoresis - p. 115 8. Chapter 8. Quality by design–based development of vibrational spectroscopy methods - p. 133 9. Chapter 9. Quality by design-based development of nondestructive analytical techniques - p. 153 10. Chapter 10. Risk assessment and design space consideration in analytical quality by design - p. 167 11. Chapter 11. Design of experiments application for analytical method development - p. 191 12. Index - p. 199
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.
1. Chapter 1. Introduction to analytical quality by design - p. 1 2. Chapter 2. Analytical quality by design for spectrophotometric method development - p. 15 3. Chapter 3. Analytical quality by design for gas chromatographic method development - p. 45 4. Chapter 4. Analytical quality by design for size-exclusion chromatography - p. 71 5. Chapter 5. Analytical quality by design for liquid chromatographic method development - p. 87 6. Chapter 6. Analytical quality by design for high-performance thin-layer chromatography method development - p. 99 7. Chapter 7. Analytical quality by design for capillary electrophoresis - p. 115 8. Chapter 8. Quality by design–based development of vibrational spectroscopy methods - p. 133 9. Chapter 9. Quality by design-based development of nondestructive analytical techniques - p. 153 10. Chapter 10. Risk assessment and design space consideration in analytical quality by design - p. 167 11. Chapter 11. Design of experiments application for analytical method development - p. 191 12. Index - p. 199
