How to Integrate Quality by Efficient Design QbED in Product Development

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

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  • Author : Bhavishya Mittal
  • Publisher : Academic Press
  • Pages : 274 pages
  • ISBN : 0128173041
  • Rating : 4/5 from 21 reviews
CLICK HERE TO GET THIS BOOKHow to Integrate Quality by Efficient Design QbED in Product Development

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
  • Release : 24 August 2019
GET THIS BOOKHow to Integrate Quality by Efficient Design (QbED) in Product Development

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

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  • Publisher : Academic Press
  • Release : 09 January 2021
GET THIS BOOKHandbook of Analytical Quality by Design

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 method. Sections cover sample preparation problems and the usefulness of the QbD concept involving Quality Risk Management (QRM), Design of Experiments (DoE) and Multivariate (MVT) Statistical Approaches to solve by

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  • Publisher : Academic Press
  • Release : 15 April 2019
GET THIS BOOKPrinciples of Parenteral Solution Validation

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  • Publisher : CRC Press
  • Release : 05 August 2016
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  • Publisher : John Wiley & Sons
  • Release : 01 September 2017
GET THIS BOOKComprehensive Quality by Design for Pharmaceutical Product Development and Manufacture

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 is seen as a framework for building process understanding, for implementing robust and effective manufacturing processes and provides the underpinnings for a science-based regulation of the pharmaceutical industry. Edited by

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  • Publisher : John Wiley & Sons
  • Release : 09 February 2009
GET THIS BOOKFormulation and Analytical Development for Low-Dose Oral Drug Products

There are unique challenges in the formulation, manufacture, analytical chemistry, and regulatory requirements of low-dose drugs. This book provides an overview of this specialized field and combines formulation, analytical, and regulatory aspects of low-dose development into a single reference book. It describes analytical methodologies like dissolution testing, solid state NMR, Raman microscopy, and LC-MS and presents manufacturing techniques such as granulation, compaction, and compression. Complete with case studies and a discussion of regulatory requirements, this is a core reference for

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  • Publisher : Elsevier Inc. Chapters
  • Release : 10 April 2013
GET THIS BOOKComputer-aided applications in pharmaceutical technology

This first chapter introduces the concept of quality-by-design (QbD) and its role in pharmaceutical product development. QbD assures the quality of a pharmaceutical product through scientific development and risk management tools, and will eventually enable real-time release, regardless of the formulation type. Several guidelines on pharmaceutical development, quality risk management, and pharmaceutical quality systems are presented that are applicable throughout the product lifecycle. Design space appointment and control strategies for risk management are introduced. The meaning of the QbD concept

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
  • Release : 30 August 2017
GET THIS BOOKComprehensive Quality by Design for Pharmaceutical Product Development and Manufacture

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 is seen as a framework for building process understanding, for implementing robust and effective manufacturing processes and provides the underpinnings for a science-based regulation of the pharmaceutical industry. Edited by

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  • Publisher : Academic Press
  • Release : 05 October 2016
GET THIS BOOKHow to Develop Robust Solid Oral Dosage Forms

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 studies, real world advice, and troubleshooting tips. By merging the latest scientific information with practical instructions, this book provides pharmaceutical scientists in formulation research and development with a concrete look

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  • Release : 08 November 2016
GET THIS BOOKDeveloping Solid Oral Dosage Forms

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, biopharmaceutics, and industrial pharmacy, and their application to the research and development process of oral dosage forms. Chapters have been added, combined, deleted, and completely revised as necessary to produce

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  • Release : 15 June 1992
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Today, a company's capability to conceive and design quality prototypes and bring a variety of superior products to market quicker than its competitors is increasingly the focal point of competition, contend leading product development experts Steven Wheelwright and Kim Clark. Drawing on six years of in-depth, systematic, worldwide research, they present proven principles for developing the critical capabilities for speed, efficiency, and quality that have worked again and again in scores of successful Japanese, American, and European fast-cycle firms. The

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  • Publisher : Springer Science & Business Media
  • Release : 27 May 2011
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Non-renewable materials can no longer be disposed once humankind's ever increasing needs cannot be fulfilled anymore due to limited resources. Reuse and recycling become inevitable requirements for product and process design. Renewable resources must not be consumed in quantities higher than can be regained. New technologies have to be developed and applied for a Sustainable Product Development and Life Cycle Engineering to fulfill the needs of humankind, protecting public health, welfare, and environment. The 8th Global Conference on Sustainable Manufacturing