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

Outsourcing has emerged as a successful business model for numerous pharmaceutical companies looking for ways to strategically increase their outsourcing capabilities and to augment their in-house resources. Quality by Efficient Design (QbED) bridges the gap between theory and practice when it comes to business making decisions in a pharmaceutical research scenario. The book will introduce the concept of QbED and focus on the 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 rooted in good science. Detailed discussions will cover pharmaceutical business models, regulatory approval process, outsourcing management, Quality by Design (QbD), business analytics, and manufacturing economics specifically for small molecules and solid oral dosage forms. With the addition of case studies, flowcharts, diagrams, and data visualizations, Quality by Efficient Design (QbED) will be a practical reference to help professionals working in the area of pharmaceutical drug development, strategy, and outsourcing management apply business acuity to pharmaceutical manufacturing operations Integrates pharmaceutical business models, economics and outsourcing management into pharmaceutical product developmentDiscusses relevant literature references in quality risk management, business strategy, QbD and product developmentProvides decision-making flowcharts, conceptual diagrams and data visualizations to make the book easy to read and understand INDICE: 1. Pharmaceutical Business 2. Outsourcing 3. Quality by Design (QbD) 4. Business Analytics 5. Manufacturing Economics 6. Quality by Efficient Design (QbED)

• ISBN: 978-0-12-816813-4
• Editorial: Academic Press
• Encuadernacion: Rústica
• Páginas: 268
• Fecha Publicación: 01/09/2019
• Nº Volúmenes: 1
• Idioma: Inglés