How to Integrate Quality by Efficient Design (QbED) in Product Development,
Edition 1
By Bhavishya Mittal

Publication Date: 27 Aug 2019

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.

Key Features

  • 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
About the author
By Bhavishya Mittal, Associate Director, Oral and Implants Product Development, Allergan plc, Irvine, CA, USA
Table of Contents

1. Health Care: A Societal Benchmark2. Pharmaceuticals: A Highly Innovative Business3. Pharmaceutical Productivity: Challenges and Opportunities4. QbD: A Welcome Evolution5. QbED: An Emerging Concept6. Adaptive Product Designs: A Wave of the Future7. Patient-Centric Drug Product Designs: A Business Necessity8. Manufacturing Excellence: Only Road to Continual Improvement9. Case Studies and Supplemental Resources

Book details
ISBN: 9780128168134
Page Count: 274
Retail Price : £115.00
  • Parikh, How to Optimize a Fluid Bed Processing Technology, Jan 2017, 9780128047279, $64.95
  • Mittal, How to Develop Robust Solid Oral Dosage Forms: From Conception to Post-Approval, Oct 2016, 9780128047316, $69.95
  • Ostrove, How to Validate a Pharmaceutical Process, Jun 2016, 9780128041482, $49.95
Pharmaceutical professionals and scientists working the area of pharmaceutical drug development, manufacturing, regulations, strategy, and outsourcing management