How to Integrate Quality by Efficient Design (QbED) in Product Development
  • Release Date : 24 August 2019
  • Publisher : Academic Press
  • Genre : Business & Economics
  • Pages : 274 pages
  • ISBN 13 : 9780128173046
Ratings: 4
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Download or read book entitled How to Integrate Quality by Efficient Design (QbED) in Product Development by author: Bhavishya Mittal which was release on 24 August 2019 and published by Academic Press with total page 274 pages . This book available in PDF, EPUB and Kindle Format. 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

Advanced Technologies for Gas Turbines

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Author : National Academies of Sciences, Engineering, and Medicine,Division on Engineering and Physical Sciences,Aeronautics and Space Engineering Board,Committee on Advanced Technologies for Gas Turbines
Publisher : National Academies Press
Genre : Science
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