How to Integrate Quality by Efficient Design QbED in Product Development

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  • Publisher : Academic Press
  • Release : 24 August 2019
  • ISBN : 9780128173046
  • Page : 274 pages
  • Rating : 4.5/5 from 103 voters

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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 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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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 Date : 2019-08-24
  • ISBN : 9780128173046
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

Handbook of Analytical Quality by Design

Handbook of Analytical Quality by Design
  • Author : Sarwar Beg,Md Saquib Hasnain,Mahfoozur Rahman,Waleed H. Almalki
  • Publisher : Academic Press
  • Release Date : 2021-01-09
  • ISBN : 9780128203330
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

Principles of Parenteral Solution Validation

Principles of Parenteral Solution Validation
  • Author : Igor Gorsky,Harold S. Baseman
  • Publisher : Academic Press
  • Release Date : 2019-04-15
  • ISBN : 9780128094129
GET THIS BOOKPrinciples of Parenteral Solution Validation

Principles of Parenteral Solution Validation: A Practical Lifecycle Approach covers all aspects involved in the development and process validation of a parenteral product. By using a lifecycle approach, this book discusses the latest technology, compliance developments, and regulatory considerations and trends, from process design, to divesting. As part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin, this book incorporates numerous case studies and real-world examples that address timely problems and offer solutions to the daily challenges

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
  • Release Date : 2017-09-01
  • ISBN : 9781119356172
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

Design for Six Sigma

Design for Six Sigma
  • Author : Elizabeth A. Cudney,Tina Kanti Agustiady
  • Publisher : CRC Press
  • Release Date : 2016-08-05
  • ISBN : 9781498742566
GET THIS BOOKDesign for Six Sigma

Design for Six Sigma (DFSS) is an innovative continuous improvement methodology for designing new products, processes, and services by integrating Lean and Six Sigma principles. This book will explain how the DFSS methodology is used to design robust products, processes, or services right the first time by using the voice of the customer to meet Six Sigma performance. Robust designs are insensitive to variation and provide consistent performance in the hands of the customer. DFSS is used to meet customer

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture
  • Author : Gintaras V. Reklaitis
  • Publisher : John Wiley & Sons
  • Release Date : 2017-10-09
  • ISBN : 9780470942376
GET THIS BOOKComprehensive Quality by Design for Pharmaceutical Product Development and Manufacture

This book is a structured approach to designing a product and its associated manufacturing process. It shows pharmaceutical engineers and scientists involved in product and process development how to utilize QbD practices and applications effectively while complying with government regulations. Material includes discussion of how to utilize design space, models, process control methodology, and cumulative process knowledge to seek improvements in manufacturing, while maintaining and enhancing product performance. Edited by three renowned researchers in the field, this invaluable resource is

Developing Solid Oral Dosage Forms

Developing Solid Oral Dosage Forms
  • Author : Yihong Qiu,Yisheng Chen,Geoff G.Z. Zhang,Lawrence Yu,Rao V. Mantri
  • Publisher : Academic Press
  • Release Date : 2016-11-08
  • ISBN : 9780128026373
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

Revolutionizing Product Development

Revolutionizing Product Development
  • Author : Steven C. Wheelwright,Kim B. Clark
  • Publisher : Simon and Schuster
  • Release Date : 1992-06-15
  • ISBN : 9780029055151
GET THIS BOOKRevolutionizing Product Development

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

How to Develop Robust Solid Oral Dosage Forms

How to Develop Robust Solid Oral Dosage Forms
  • Author : Bhavishya Mittal
  • Publisher : Academic Press
  • Release Date : 2016-10-05
  • ISBN : 9780128047323
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

Design of Experiments for Pharmaceutical Product Development

Design of Experiments for Pharmaceutical Product Development
  • Author : Sarwar Beg
  • Publisher : Springer Nature
  • Release Date : 2021-01-12
  • ISBN : 9789813347175
GET THIS BOOKDesign of Experiments for Pharmaceutical Product Development

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 dedicated case studies on various pharmaceutical experiments through illustrations, art-works, tables and figures. This book is a valuable guide for all academic and industrial researchers, pharmaceutical and biomedical scientists, undergraduate

Formulation and Analytical Development for Low-Dose Oral Drug Products

Formulation and Analytical Development for Low-Dose Oral Drug Products
  • Author : Jack Zheng
  • Publisher : John Wiley & Sons
  • Release Date : 2009-02-09
  • ISBN : 9780470056097
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

Computer-aided applications in pharmaceutical technology

Computer-aided applications in pharmaceutical technology
  • Author : Jelena Djuris,Svetlana Ibric,Zorica Djuric
  • Publisher : Elsevier Inc. Chapters
  • Release Date : 2013-04-10
  • ISBN : 9780128091876
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

Improvement of Buildings' Structural Quality by New Technologies

Improvement of Buildings' Structural Quality by New Technologies
  • Author : Christian Schauer,ENG. Federico Mazzolani,Gerald Huber,Gianfranco de Matteis,Heiko Trumpf,Heli Koukkari,Jean-Pierre Jaspart,Luis Bragança
  • Publisher : CRC Press
  • Release Date : 2005-01-20
  • ISBN : 0415366097
GET THIS BOOKImprovement of Buildings' Structural Quality by New Technologies

Launched in May 2000, the aims of the COST C12 cooperative action were: to develop, combine and disseminate new technical engineering technologies to improve the quality of urban buildings to propose new technical solutions to architects and planners to reduce the disturbance caused by construction in urban areas and improve urban quality of life. This volume contains the proceedings of the COST C12 final conference held in Innsbruck, Austria from January 20-22 2005. The book reflects not only the outcome of the

Setting the PACE in Product Development

Setting the PACE in Product Development
  • Author : Michael E. McGrath
  • Publisher : Routledge
  • Release Date : 1996
  • ISBN : 9780750697897
GET THIS BOOKSetting the PACE in Product Development

Setting the PACE in Product Development describes how to effectively manage the key ingredients of successful product development: time, quality, talent and resources. This revised edition of Product Development provides essential insight as to how to efficiently organize people, resources and processes to dramatically improve financial results, strategic positions, internal morale and customer satisfaction. The PACE techniques integrate vital company-wide functions, engaging the entire company and focusing its collective energy on strategically and financially important goals. Previously in hardback, now

Chemical Product Design

Chemical Product Design
  • Author : E. L. Cussler,Edward Lansing Cussler,G. D. Moggridge,G. D.. Moggridge
  • Publisher : Cambridge University Press
  • Release Date : 2001-04-16
  • ISBN : 0521791839
GET THIS BOOKChemical Product Design

Ground-breaking text on chemical product design covering needs, ideas, selection, manufacture.