Handbook of Analytical Quality by Design
Coordonnateurs : Beg Sarwar, Hasnain Md Saquib, Rahman Mahfoozur, H Almalki Waleed
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.
2. Analytical Quality by Design for spectrophotometric method development
3. Analytical Quality by Design for liquid chromatographic method development
4. Analytical Quality by Design for gas chromatographic method development
5. Analytical Quality by Design for size-exclusion chromatography
6. Analytical Quality by Design for ion-exchange chromatography
7. Analytical Quality by Design for LC-MS/MS method development
8. Analytical Quality by Design for HPTLC method development
9. Analytical Quality by Design for capillary electrophoresis
10. Quality by Design based development of vibrational spectroscopy methods
11. Quality by Design based development of atomic absorption spectroscopy methods
12. Quality by Design based development of non-destructive analytical techniques
13. Design space considerations for flexibility in analytical method development
Graduate students and professionals working in the pharmaceutical industry, analytical chemistry, regulatory agencies, and those in related academic fields
Prof. (Dr.) Md Saquib Hasnain has over 10 years of research experience in the field of drug delivery and pharmaceutical formulation analyses, especially systematic development and characterization of diverse nanostructured drug delivery systems, controlled release drug delivery systems, bioenhanced drug delivery systems, nanomaterials and nanocomposites employing Quality by Design approaches and many more. Till date he has authored over 70 publications in various high impact peer-reviewed journals, more than 100 book chapters and 16 books to his credit. He is also serving as the reviewer of several prestigious journals. Overall, he has earned a highly impressive publishing and cited record in Google Scholar (h-index: 32). He has also participated and presented his research work at over ten conferences in India, and abroad. He was also a member of scientific societies i.e., Royal Society of Chemistry, Great Britain, International Association of Environmental and Analytical Chemistry, Switzerland and Swiss Chemical Society, Switzerland.
Mahfoozur Rahman is an Assistant Professor at the Department of Pharmaceutical Sciences, Faculty of H
- 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
Date de parution : 01-2021
Ouvrage de 222 p.
15x22.8 cm
Thèmes de Handbook of Analytical Quality by Design :
Mots-clés :
?Analytical development; Analytical quality by design; Analytical target profile; Analytical testing; CMA; CMP; Design of experiment; Design of experiments; Design space; Drug delivery; Experimental design; Experimental designs; Gas chromatography; Gel permeation chromatography; HPTLC; Ion-exchange chromatography; Liquid chromatography; MODR; Macromolecules; Method development; Method validation UV-visible spectrometry; Method variability; Multivariate testing; Nondestructive techniques; Pharmaceuticals; Process analytical tool (PAT); Product quality; Product robustness; Quality by design; Quality by design (QbD); Quality-by-design; Real-time analysis; Risk assessment; Robustness; Ruggedness; Sensitivity; Size-exclusion chromatography; Spectrofluorimetry; Variability; Vibrational spectroscopy
