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.
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Table of Contents
1. 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
Authors
Sarwar Beg Assistant Professor, Department of Pharmaceutics, School of Pharmaceutical Education and Research, Jamia Hamdard University, New Delhi, India.
Sarwar Beg, PhD is currently serving as AMS-DBT Newton International Fellow at University of Central Lancashire, UK, and working in the area of glioblastoma research using targeted nanomedicines. He is also serving as the Assistant Professor at Department of Pharmaceutics, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi. He has over a decade of teaching and research experience in the field of pharmaceutics and biopharmaceutics, especially in the development of novel and nanostructured drug delivery systems using Quality-by-Design paradigms with core expertise in computational pharmaceutics, experimental designs and multivariate statistical techniques. He has authored over 200 publications, 60 book chapters, 15 books, 03 Indian patent applications and H-Index of 40 with over 5400 citations to his credit.
Md Saquib Hasnain Department of Pharmacy, Palamau Institute of Pharmacy, Daltonganj, Jharkhand, India.
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 Assistant Professor, Department of Pharmaceutical Sciences, Sam Higginbottom University of Agriculture, Technology and Sciences, Allahabad, India.
Mahfoozur Rahman is an Assistant Professor at the Department of Pharmaceutical Sciences, Faculty of Health Science, Sam Higginbottom University of Agriculture, Technology & Sciences (SHUATS), Allahabad, India. He has authored more than 130 publications in peer-reviewed journals, 30 book chapters, seven books, and four articles in international magazines with various publishers. He has a Google Scholar h-index of 27 and over 1700 citations to his credit. He also serves on the editorial boards and as guest editor for several journals. He has received travel grants from various international congresses, such as IAPRD, MDS, Nano Today, KSN and WCN, on the basis of his research work and contribution in the field.
Waleed H Almalki Associate Professor, Department of Pharmacology and Toxicology, College of Pharmacy, Umm Al-Qura University, Makkah, Saudi Arabia.
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.
