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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
- 9th January 2021
- Academic Press
- Paperback ISBN:
- eBook ISBN:
Sarwar Beg is 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. 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.
Assistant Professor, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi, India
Dr Md Saquib Hasnain, PhD, has more than six years of research experience in the field of pharmaceutics, especially in systematic development and characterization of diverse nanostructured drug delivery systems, controlled release drug delivery systems, bio-enhanced drug delivery systems, nanomaterials, and nanocomposites, employing quality-by-design approaches, as well as development and characterization of polymeric composites, and formulation characterization. To date, he has authored more than 30 publications in various high impact peer-reviewed journals, 37 book chapters, and co-edited 10 books. He has one Indian patent application and serves as a reviewer for several journals. Dr Hasnain has participated in, and presented his research work at, several conferences in India and abroad. He is a member of the Royal Society of Chemistry, UK, the International Association of Environmental and Analytical Chemistry, Switzerland, and the Swiss Chemical Society.
Department of Pharmacy, Palamau Institute of Pharmacy, Chianki, Daltonganj, Jharkhand, India
Mahfoozur Rahman, PhD, is an Assistant Professor at the Department of Pharmaceutical Sciences, Faculty of Health Science, Sam Higginbottom University of Agriculture, Technology & Sciences (SHUATS), Allahabad, India. His major areas of research interest include development and characterization of nanosized drug delivery systems for inflammatory disorders including psoriasis, arthritis, neurodegenerative disorders and cancer, etc. Besides, he is also working on amalgamation of herbal medicinal plants with modern therapeutics in order to deliver a scientifically acceptable therapy for various diseases management. To date he has published over 100 publications in peer reviewed journals.
Assistant Professor, Department of Pharmaceutical Sciences, Faculty of Health Science, Sam Higginbottom University of Agriculture, Technology and Sciences (SHUATS), Allahabad, India
Dr. Waleed Hassan Almalki is an associate professor of pharmacology at the college of pharmacy, Umm Al-Qura University, Makkah, Saudi Arabia. He earned his doctoral degree from the University of Glasgow, United Kingdom having a dissertation on ocular pharmacology. His current research is focused on the broad areas of host-virus networks in hepacivirus C disease progression as well as host-virus genes expression during oxidative stress, hepatic steatosis, fibrosis, and hepatocellular carcinoma. He is also enthusiastically involved in the studies of tyrosine kinase inhibitors for the treatment of breast and colon cancer, in the Saudi population. Dr. Waleed has published many research and review articles in peer-reviewed international journals on HCV pathogenesis, treatment and drug designing as well as edited various book chapters about pathological angiogenesis, pharmacological assays and infectious disease epidemiology.
Department of Pharmacology and Toxicology, College of Pharmacy, Umm Al-Qura University, Makkah, Saudi Arabia
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