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.
1. Cover image - p. i 2. Title page - p. ii 3. Table of Contents - p. iii 4. Copyright - p. iv 5. Dedication - p. v 6. How to Use - p. vii 7. Biography of Bhavishya Mittal - p. xv 8. Foreword - p. xvii 9. Acknowledgments - p. xix 10. About the Expertise in Pharmaceutical Process Technology series - p. xxi 11. Chapter 1. Healthcare: a societal benchmark - p. 1 12. Chapter 2. Pharmaceuticals: a highly innovative business - p. 27 13. Chapter 3. Pharmaceutical productivity: challenges and opportunities - p. 59 14. Chapter 4. QbD: a welcome evolution - p. 87 15. Chapter 5. QbED: an emerging concept - p. 115 16. Chapter 6. Adaptive product designs: a wave of the future - p. 141 17. Chapter 7. Patient-centric drug product designs: a business necessity - p. 165 18. Chapter 8. Manufacturing excellence: only road to continual improvement - p. 191 19. Chapter 9. Case studies and supplemental resources - p. 215 20. Index - p. 245
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.
1. Cover image - p. i 2. Title page - p. ii 3. Table of Contents - p. iii 4. Copyright - p. iv 5. Dedication - p. v 6. How to Use - p. vii 7. Biography of Bhavishya Mittal - p. xv 8. Foreword - p. xvii 9. Acknowledgments - p. xix 10. About the Expertise in Pharmaceutical Process Technology series - p. xxi 11. Chapter 1. Healthcare: a societal benchmark - p. 1 12. Chapter 2. Pharmaceuticals: a highly innovative business - p. 27 13. Chapter 3. Pharmaceutical productivity: challenges and opportunities - p. 59 14. Chapter 4. QbD: a welcome evolution - p. 87 15. Chapter 5. QbED: an emerging concept - p. 115 16. Chapter 6. Adaptive product designs: a wave of the future - p. 141 17. Chapter 7. Patient-centric drug product designs: a business necessity - p. 165 18. Chapter 8. Manufacturing excellence: only road to continual improvement - p. 191 19. Chapter 9. Case studies and supplemental resources - p. 215 20. Index - p. 245
