Pharmaceutical Quality by Design: Principles and Applications
Language: English
Published by Academic Press, 2019
- First Edition
- Softcover
- New
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Seller Inventory # V9780128157992
- Title
- Pharmaceutical Quality by Design: Principles and Applications
- Publisher
- Academic Press
- Publication year
- 2019
- Condition
- New
- Binding
- Soft cover
- Language
- English
- ISBN 10
- 0128157992
- ISBN 13
- 9780128157992
- Edition
- 1st Edition
Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book walks readers through the QbD framework by covering the fundamental principles of QbD, the current regulatory requirements, and the applications of QbD at various stages of pharmaceutical product development, including drug substance and excipient development, analytical development, formulation development, dissolution testing, manufacturing, stability studies, bioequivalence testing, risk and assessment, and clinical trials.
Contributions from global leaders in QbD provide specific insight in its application in a diversity of pharmaceutical products, including nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of illustrations, practical examples, and case studies makes this book a useful reference guide to pharmaceutical scientists and researchers who are engaged in the formulation of various delivery systems and the analysis of pharmaceutical product development and drug manufacturing process.
"Synopsis" may belong to another edition of this title.
About the Author
Md Saquib Hasnain (Ph.D) is currently working as the Professor and Dean, Department of Pharmaceutical Technology, School of Health and Medical Sciences, Barasat, Kolkata, West Bengal, India. He has over 13 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 100 publications in various high impact peer-reviewed journals, more than 100 book chapters and 30 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. 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.
"About the title" may belong to another edition of this title.
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