Pharmaceutical Quality by Design
  • Author : Sarwar Beg
  • Release Date : 27 March 2019
  • Publisher : Academic Press
  • Genre : Business & Economics
  • Pages : 448
  • ISBN 13 : 9780128163726

Pharmaceutical Quality by Design Book Summary

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

Pharmaceutical Quality by Design

Pharmaceutical Quality by Design

Author : Sarwar Beg,Md Saquib Hasnain
Publisher : Academic Press
Genre : Business & Economics
Total View : 7154 Views
File Size : 41,8 Mb
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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 ...

Pharmaceutical Quality by Design

Pharmaceutical Quality by Design

Author : Walkiria S. Schlindwein,Mark Gibson
Publisher : John Wiley & Sons
Genre : Science
Total View : 4821 Views
File Size : 51,6 Mb
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A practical guide to Quality by Design for pharmaceutical product development Pharmaceutical Quality by Design: A Practical Approach outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. Written by experts in the field, the text explores the QbD ...

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture

Author : Gintaras V. Reklaitis,Christine Seymour,Salvador García-Munoz
Publisher : John Wiley & Sons
Genre : Science
Total View : 4796 Views
File Size : 55,9 Mb
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Covers a widespread view of Quality by Design (QbD) encompassing the many stages involved in the development of a new drug product. The book provides a broad view of Quality by Design (QbD) and shows how QbD concepts and analysis facilitate the development and manufacture of high quality products. QbD ...

Handbook of Analytical Quality by Design

Handbook of Analytical Quality by Design

Author : Sarwar Beg,Md Saquib Hasnain,Mahfoozur Rahman,Waleed H. Almalki
Publisher : Academic Press
Genre : Business & Economics
Total View : 2536 Views
File Size : 42,7 Mb
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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 ...

Pharmaceutical Quality by Design

Pharmaceutical Quality by Design

Author : Walkiria S. Schlindwein,Mark Gibson
Publisher : John Wiley & Sons
Genre : Science
Total View : 1015 Views
File Size : 42,6 Mb
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A practical guide to Quality by Design for pharmaceutical product development Pharmaceutical Quality by Design: A Practical Approach outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. Written by experts in the field, the text explores the QbD ...

Introduction to Quality by Design for Pharmaceuticals

Introduction to Quality by Design for Pharmaceuticals

Author : Nilesh Desai,Manohar A Potdar
Publisher : Pharmamed Press
Genre : Design
Total View : 6948 Views
File Size : 52,8 Mb
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Quality by design (QbD) is extensively used tool in formulation and development. QbD is a method of choice in product development for robust and quality product incorporating continuous improvement. The objective of the book is to study the implementation of QbD and wide-ranging QbD based product development template for different ...

Pharmaceutical Quality by Design Using JMP

Pharmaceutical Quality by Design Using JMP

Author : Rob Lievense
Publisher : Unknown
Genre : Computers
Total View : 5690 Views
File Size : 41,7 Mb
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Solve your pharmaceutical product development and manufacturing problems using JMP®. Pharmaceutical Quality by Design Using JMP®: Solving Product Development and Manufacturing Problems provides broad-based techniques available in JMP to visualize data and run statistical analyses for areas common in healthcare product manufacturing. As international regulatory agencies push the concept of ...

Quality by Design for Biopharmaceuticals

Quality by Design for Biopharmaceuticals

Author : Anurag S. Rathore,Rohin Mhatre
Publisher : John Wiley & Sons
Genre : Science
Total View : 1025 Views
File Size : 47,5 Mb
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The concepts, applications, and practical issues of Quality byDesign Quality by Design (QbD) is a new framework currently beingimplemented by the FDA, as well as EU and Japanese regulatoryagencies, to ensure better understanding of the process so as toyield a consistent and high-quality pharmaceutical product. QbDbreaks from past approaches in ...