How to Integrate Quality by Efficient Design (QbED) in Product Development
  • Author : Bhavishya Mittal
  • Release Date : 24 August 2019
  • Publisher : Academic Press
  • Genre : Business & Economics
  • Pages : 274
  • ISBN 13 : 9780128173046

How to Integrate Quality by Efficient Design (QbED) in Product Development Book Summary

The development of a robust drug product requires juggling many competing priorities such as overcoming scientific challenges, following regulatory requirements, and managing business-related concerns. Unfortunately, despite large resources spent on R&D, multifactor productivity of pharmaceuticals is on the decline for several years now. Because of this business reality, pharmaceutical companies have seen a notable change in the traditional operating model and footprint over the past couple of decades. Outsourcing, in particular, has emerged as a successful business model for many pharmaceutical companies looking for ways to strategically increase their R&D capabilities and to augment their in-house resources. How to Integrate Quality by Efficient Design (QbED) in Product Development bridges the gap between theory and practice when it comes to strategic decision-making in a pharmaceutical research scenario. This book will introduce the concept of QbED and focus on various aspects such as patient-centric product designs, platform-based manufacturing technologies, business acuity, and regulatory strategies to balance the challenges in outsourcing with the need for strategic and statistically sound experiments rooted in good science. Detailed discussions will cover pharmaceutical business models, regulatory approval process, quality by design (QbD), business analytics, and manufacturing excellence specifically for small molecules and solid oral dosage forms. With the addition of case studies, flowcharts, diagrams, and data visualizations, How to Integrate Quality by Efficient Design (QbED) in Product Development will be a practical reference to help professionals working in the area of pharmaceutical drug development, strategy, and outsourcing management. Part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin Integrates pharmaceutical business models, economics, and outsourcing-related challenges into pharmaceutical product development Discusses relevant literature references in quality risk management, business strategy, QbD, and product development Provides decision-making flowcharts, conceptual diagrams, and data visualizations to make the book useful, easy to read, and to understand

How to Integrate Quality by Efficient Design  QbED  in Product Development

How to Integrate Quality by Efficient Design QbED in Product Development

Author : Bhavishya Mittal
Publisher : Academic Press
Genre : Business & Economics
Total View : 3991 Views
File Size : 51,9 Mb
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The development of a robust drug product requires juggling many competing priorities such as overcoming scientific challenges, following regulatory requirements, and managing business-related concerns. Unfortunately, despite large resources spent on R&D, multifactor productivity of pharmaceuticals is on the decline for several years now. Because of this business reality, pharmaceutical ...

How to Integrate Quality by Efficient Design  QbED  in Product Development

How to Integrate Quality by Efficient Design QbED in Product Development

Author : Bhavishya Mittal
Publisher : Academic Press
Genre : Business & Economics
Total View : 7761 Views
File Size : 45,8 Mb
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How to Integrate Quality by Efficient Design (QbED) in Product Development Outsourcing introduces the concept of QbED and focuses on various product design options, manufacturing technologies, business economics and regulatory strategies to balance the challenges in outsourcing with the need for strategic and statistically sound experiments that are rooted in ...

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 : 6998 Views
File Size : 41,8 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 ...

Principles of Parenteral Solution Validation

Principles of Parenteral Solution Validation

Author : Igor Gorsky,Harold S. Baseman
Publisher : Academic Press
Genre : Medical
Total View : 3168 Views
File Size : 44,9 Mb
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Principles of Parenteral Solution Validation: A Practical Lifecycle Approach covers all aspects involved in the development and process validation of a parenteral product. By using a lifecycle approach, this book discusses the latest technology, compliance developments, and regulatory considerations and trends, from process design, to divesting. As part of the ...

Revolutionizing Product Development

Revolutionizing Product Development

Author : Steven C. Wheelwright,Kim B. Clark
Publisher : Simon and Schuster
Genre : Business & Economics
Total View : 8046 Views
File Size : 40,9 Mb
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Today, a company's capability to conceive and design quality prototypes and bring a variety of superior products to market quicker than its competitors is increasingly the focal point of competition, contend leading product development experts Steven Wheelwright and Kim Clark. Drawing on six years of in-depth, systematic, worldwide research, they ...

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 : 3912 Views
File Size : 40,6 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 ...

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 : 9192 Views
File Size : 49,8 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 ...

Setting the PACE in Product Development

Setting the PACE in Product Development

Author : Michael E. McGrath
Publisher : Routledge
Genre : Technology & Engineering
Total View : 1013 Views
File Size : 54,7 Mb
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Setting the PACE in Product Development describes how to effectively manage the key ingredients of successful product development: time, quality, talent and resources. This revised edition of Product Development provides essential insight as to how to efficiently organize people, resources and processes to dramatically improve financial results, strategic positions, internal ...