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Pharmaceutical Quality by Design

  • ID: 4720884
  • Book
  • March 2019
  • Region: Global
  • 448 Pages
  • Elsevier Science and Technology
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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.

  • Discusses vital QbD precepts and fundamental aspects of QbD implementation in the pharma, biopharma and biotechnology industries
  • Provides helpful illustrations, practical examples and research case studies to explain QbD concepts to readers
  • Includes contributions from global leaders and experts from academia, industry and regulatory agencies

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1. Introduction to Quality by Design (QbD): Fundamentals, principles 2. Global regulatory perspectives on Quality by Design in pharma manufacturing 3. Application of Design of Experiments (DoE) in pharmaceutical product and process optimization 4. QbD considerations for excipient manufacturing 5. QbD considerations for analytical development 6. Application of Quality by Design paradigms for development of solid dosage forms 7. QbD considerations for topical and transdermal product development 8. Qbd based development of pharmaceutical parenteral drug products: An overview 9. Quality by design considerations for product development of dry-powder inhalers 10. QbD considerations for development of lyophilized products 11. Application of quality by design approach for hot-melt extrusion process optimization 12. QbD applications for development of nanopharmaceutical products 13. Application of QbD principles in nanocarrier based drug delivery systems 14. Application of QbD framework for development of self-emulsifying drug delivery systems 15. 'Quality by Design' approach for development of multiparticulate drug delivery systems 16. Application of QbD elements for development of vesicular drug delivery systems 17. Emergence of quality by design in extraction technology for bioactive compounds 18. Application of quality by design for the development of biopharmaceuticals

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Beg, Sarwar
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”.
Hasnain, Md Saquib
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.
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