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

Erscheinungsjahr 2019
ISBN: 978-0-12-816813-4
Verlag: Elsevier Science Publishing Co Inc

Buch, Englisch, 274 Seiten, Format (B × H): 152 mm x 229 mm, Gewicht: 430 g

Reihe: Expertise in Pharmaceutical Process Technology

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.

Zielgruppe

Pharmaceutical professionals and scientists working the area of pharmaceutical drug development, manufacturing, regulations, strategy, and outsourcing management

Autoren/Hrsg.

Mittal, Bhavishya

Fachgebiete

• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Pharmazie
• Wirtschaftswissenschaften Wirtschaftssektoren & Branchen Fertigungsindustrie Pharmaindustrie

Inhaltsverzeichnis

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

Über Autor(innen)

Mittal, Bhavishya
Bhavishya Mittal is the Vice-President of Product Development and Manufacturing at BioDuro-Sundia (Irvine, CA), where he leads the strategy and operations for drug product development of all small molecule client-owned assets within the portfolio. Before BioDuro, Bhavi worked at Kronos Bio, AbbVie, US FDA, Takeda, and Astellas Pharmaceuticals. Bhavi is also an adjunct faculty at the Keck Graduate Institute's Henry E. Riggs School of Applied Life Sciences (Claremont, CA). He has a Ph.D. in Materials Engineering from the Pennsylvania State University and a BS in Chemical and Bio Engineering from the National Institute of Technology, Jalandhar (India). Bhavi has 21+ years of industrial experience in the formulation design, process development, and project management of numerous drug products of small therapeutic molecules (oncology, inflammation, GI, and CNS indications) aimed for NDA, BLA, and ANDA filings. He is the Chair for the Manufacturing Sciences and Engineering (MSE) community of AAPS. He is the author of 3 published books (with 25 combined chapters), 4 granted US patents, 11 peer-reviewed manuscripts, and numerous conference papers and posters published/presented in various international journals and conferences. He is also very active in organizing conferences and moderating technical sessions on cutting-edge topics related to pharmaceutical manufacturing sciences.