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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
Graduate students and professionals working in the pharmaceutical industry, analytical chemistry, regulatory agencies, and those in related academic fields
- Introduction to analytical quality by design
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
- No. of pages:
- © Academic Press 2021
- 1st December 2020
- Academic Press
- Paperback ISBN:
Dr. Sarwar Beg is currently serving as Assistant Professor at Department of Pharmaceutics, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi, India. Prior to joining Jamia Hamdard, Dr. Sarwar was worked with Jubilant Generics Limited, Noida, as Research Scientist and was responsible for QbD implementation in formulation and analytical development of generic products. He has over a decade of experience in the field of pharmaceutics, especially in the systematic development and characterization of novel and nanostructured drug delivery systems employing Quality by Design (QbD), Design of Experiments (DoE) and multivariate statistical approaches. Besides, Dr. Sarwar has good knowledge in applying various other advanced computational tools like drug release kinetic modeling, pharmacokinetic modeling and in vitro/in vivo correlation (IVIVC) approaches for efficient development of drug products. Till date, he has authored over 125 publications in various peer-reviewed journals, 35 book chapters, 7 books and 3 Indian Patent applications to his credit. Overall, he has earned highly impressive published and cited record with H-Index of 21 and over 2000 citations to his credit. Dr. Beg has participated and presented his research work at several conferences in USA, Canada, China, India, Bangladesh, and has earned several “Best Paper” awards. He has also been awarded with “Innovative Pharma Research Award 2016” by SIPRA Lab (Hyderabad), “Eudragit® Award 2014” in South-Asia by M/s Evonik GmbH (Germany), “Budding QbD Scientist Award 2014” and “Budding ADME Scientist Award 2013” by M/s Select Biosciences (UK) and “Novartis Biotechnology Leadership Award 2012” (Hyderabad). In April 2017, Dr. Sarwar was felicitated by Hon’ble Union Health Minister of India, and Managing Director, Sun Pharma, with prestigious “Sun Pharma Science Foundation - Young Scientist Award”.
Department of Pharmaceutics School of Pharmaceutical Education and Research, Jamia Hamdard (Hamdard University), New Delhi, India
Dr. Md Saquib Hasnain has over 6 years of research experience in the field of drug delivery and pharmaceutical formulation and analyses; especially systematic development and characterization of diverse nanostructured drug delivery systems, controlled release drug delivery systems, bioenhanced drug delivery systems, polymeric composites, nanomaterials and nanocomposites employing Quality by Design approaches. Till date he has authored over 30 publications in various high impact peer-reviewed journals, around 30 book chapters, 1 Indian patent application and 4 books to his credit. He is also serving as the reviewer of several prestigious journals. He is also serving as the associate editorial board member of Recent Patent on Drug Delivery & Formulation journal. Overall, he has earned highly impressive publishing and cited record in Google Scholar (H-Index: 12). He has also participated and presented his research work at over ten conferences in India, and abroad. He is also the 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.
Department of Pharmacy, Shri Venkateshwara University, Gajraula, U.P., India
Mahfoozur Rahman is Assistant Professor, at the Department of Pharmaceutics, Shalom Institute of Health and Allied Sciences, Sam Higginbottom University of Agriculture, Technology & Sciences, India. His research focuses in the areas of novel and nanostructured drug delivery systems, for autoimmune-based inflammatory disorders, CNS disorders and cancer.
Department of Pharmaceutical Sciences, Sam Higginbottom University of Agriculture, Technology and Sciences, Allahabad, UP, India
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