How to Integrate Quality by Efficient Design (QbED) in Product Development
  • Author : Bhavishya Mittal
  • Release Date : 24 August 2019
  • Publisher : Academic Press
  • Genre : Business & Economics
  • Pages : 274
  • ISBN 13 : 9780128173046

Download Or Read How to Integrate Quality by Efficient Design (QbED) in Product Development eBook PDF

Book excerpt: 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

How to Integrate Quality by Efficient Design  QbED  in Product Development

How to Integrate Quality by Efficient Design QbED in Product Development

Author : Bhavishya Mittal
Publisher : Academic Press
Genre : Business & Economics
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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 ...

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Publisher : Academic Press
Genre : Business & Economics
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Handbook of Analytical Quality by Design addresses the steps involved in analytical method development and validation in an effort to avoid quality crises in later stages. The AQbD approach significantly enhances method performance and robustness which are crucial during inter-laboratory studies and also affect the analytical lifecycle of the developed ...

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Publisher : Academic Press
Genre : Medical
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Publisher : CRC Press
Genre : Technology & Engineering
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Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture

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Author : Gintaras V. Reklaitis,Christine Seymour,Salvador García-Munoz
Publisher : John Wiley & Sons
Genre : Science
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Covers a widespread view of Quality by Design (QbD) encompassing the many stages involved in the development of a new drug product. The book provides a broad view of Quality by Design (QbD) and shows how QbD concepts and analysis facilitate the development and manufacture of high quality products. QbD ...

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture

Author : Gintaras V. Reklaitis,Christine Seymour,Salvador García-Munoz
Publisher : John Wiley & Sons
Genre : Science
Get Book

Covers a widespread view of Quality by Design (QbD) encompassing the many stages involved in the development of a new drug product. The book provides a broad view of Quality by Design (QbD) and shows how QbD concepts and analysis facilitate the development and manufacture of high quality products. QbD ...

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Publisher : Academic Press
Genre : Medical
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Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, Second Edition illustrates how to develop high-quality, safe, and effective pharmaceutical products by discussing the latest techniques, tools, and scientific advances in preformulation investigation, formulation, process design, characterization, scale-up, and production operations. This book covers the essential principles of physical pharmacy, ...

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Publisher : Simon and Schuster
Genre : Business & Economics
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How to Develop Robust Solid Oral Dosage Forms

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Author : Bhavishya Mittal
Publisher : Academic Press
Genre : Medical
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How to Develop Robust Solid Oral Dosage Forms from Conception to Post-Approval uses a practical and hands-on approach to cover the development process of solid oral dosage forms in one single source. The book details all of the necessary steps from formulation through the post-approval phase and contains industry case ...

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Publisher : Springer Nature
Genre : Medical
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This book volume provides complete and updated information on the applications of Design of Experiments (DoE) and related multivariate techniques at various stages of pharmaceutical product development. It discusses the applications of experimental designs that shall include oral, topical, transdermal, injectables preparations, and beyond for nanopharmaceutical product development, leading to ...

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Publisher : John Wiley & Sons
Genre : Medical
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Publisher : Elsevier Inc. Chapters
Genre : Technology & Engineering
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Genre : Technology & Engineering
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