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Author: Sarwar Beg
Publisher: Academic Press
ISBN: 0128163720
Category : Business & Economics
Languages : en
Pages : 448
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Book Description
Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book walks readers through the QbD framework by covering the fundamental principles of QbD, the current regulatory requirements, and the applications of QbD at various stages of pharmaceutical product development, including drug substance and excipient development, analytical development, formulation development, dissolution testing, manufacturing, stability studies, bioequivalence testing, risk and assessment, and clinical trials. Contributions from global leaders in QbD provide specific insight in its application in a diversity of pharmaceutical products, including nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of illustrations, practical examples, and case studies makes this book a useful reference guide to pharmaceutical scientists and researchers who are engaged in the formulation of various delivery systems and the analysis of pharmaceutical product development and drug manufacturing process. Discusses vital QbD precepts and fundamental aspects of QbD implementation in the pharma, biopharma and biotechnology industries Provides helpful illustrations, practical examples and research case studies to explain QbD concepts to readers Includes contributions from global leaders and experts from academia, industry and regulatory agencies
Author: Sarwar Beg
Publisher: Academic Press
ISBN: 0128163720
Category : Business & Economics
Languages : en
Pages : 448
Get Book Here
Book Description
Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book walks readers through the QbD framework by covering the fundamental principles of QbD, the current regulatory requirements, and the applications of QbD at various stages of pharmaceutical product development, including drug substance and excipient development, analytical development, formulation development, dissolution testing, manufacturing, stability studies, bioequivalence testing, risk and assessment, and clinical trials. Contributions from global leaders in QbD provide specific insight in its application in a diversity of pharmaceutical products, including nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of illustrations, practical examples, and case studies makes this book a useful reference guide to pharmaceutical scientists and researchers who are engaged in the formulation of various delivery systems and the analysis of pharmaceutical product development and drug manufacturing process. Discusses vital QbD precepts and fundamental aspects of QbD implementation in the pharma, biopharma and biotechnology industries Provides helpful illustrations, practical examples and research case studies to explain QbD concepts to readers Includes contributions from global leaders and experts from academia, industry and regulatory agencies
Author: Walkiria S. Schlindwein
Publisher: John Wiley & Sons
ISBN: 1118895215
Category : Science
Languages : en
Pages : 319
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Book Description
A practical guide to Quality by Design for pharmaceutical product development Pharmaceutical Quality by Design: A Practical Approach outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. Written by experts in the field, the text explores the QbD approach to product development. This innovative approach is based on the application of product and process understanding underpinned by a systematic methodology which can enable pharmaceutical companies to ensure that quality is built into the product. Familiarity with Quality by Design is essential for scientists working in the pharmaceutical industry. The authors take a practical approach and put the focus on the industrial aspects of the new QbD approach to pharmaceutical product development and manufacturing. The text covers quality risk management tools and analysis, applications of QbD to analytical methods, regulatory aspects, quality systems and knowledge management. In addition, the book explores the development and manufacture of drug substance and product, design of experiments, the role of excipients, multivariate analysis, and include several examples of applications of QbD in actual practice. This important resource: Covers the essential information about Quality by Design (QbD) that is at the heart of modern pharmaceutical development Puts the focus on the industrial aspects of the new QbD approach Includes several illustrative examples of applications of QbD in practice Offers advanced specialist topics that can be systematically applied to industry Pharmaceutical Quality by Design offers a guide to the principles and application of Quality by Design (QbD), the holistic approach to manufacturing that offers a complete understanding of the manufacturing processes involved, in order to yield consistent and high quality products.
Author: Sarwar Beg
Publisher: Academic Press
ISBN: 0128203331
Category : Business & Economics
Languages : en
Pages : 225
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Book Description
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 optimizing the developed method, along with validation for different techniques like HPLC, UPLC, UFLC, LC-MS and electrophoresis. This will be an ideal resource for graduate students and professionals working in the pharmaceutical industry, analytical chemistry, regulatory agencies, and those in related academic fields. Concise language for easy understanding of the novel and holistic concept Covers key aspects of analytical development and validation Provides a robust, flexible, operable range for an analytical method with greater excellence and regulatory compliance
Author: Bhavishya Mittal
Publisher: Academic Press
ISBN: 0128173041
Category : Business & Economics
Languages : en
Pages : 274
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Book Description
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
Author: Gintaras V. Reklaitis
Publisher: John Wiley & Sons
ISBN: 0470942371
Category : Science
Languages : en
Pages : 418
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Book Description
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 the three renowned researchers in the field, Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture guides pharmaceutical engineers and scientists involved in product and process development, as well as teachers, on how to utilize QbD practices and applications effectively while complying with government regulations. The material is divided into three main sections: the first six chapters address the role of key technologies, including process modeling, process analytical technology, automated process control and statistical methodology in supporting QbD and establishing the associated design space. The second section consisting of seven chapters present a range of thoroughly developed case studies in which the tools and methodologies discussed in the first section are used to support specific drug substance and drug-product QbD related developments. The last section discussed the needs for integrated tools and reviews the status of information technology tools available for systematic data and knowledge management to support QbD and related activities. Highlights Demonstrates Quality by Design (QbD) concepts through concrete detailed industrial case studies involving of the use of best practices and assessment of regulatory implications Chapters are devoted to applications of QbD methodology in three main processing sectors—drug substance process development, oral drug product manufacture, parenteral product processing, and solid-liquid processing Reviews the spectrum of process model types and their relevance, the range of state-of-the-art real-time monitoring tools and chemometrics, and alternative automatic process control strategies and methods for both batch and continuous processes The role of the design space is demonstrated through specific examples and the importance of understanding the risk management aspects of design space definition is highlighted Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture is an ideal book for practitioners, researchers, and graduate students involved in the development, research, or studying of a new drug and its associated manufacturing process.
Author: N. Logothetis
Publisher: Oxford University Press, USA
ISBN:
Category : Business & Economics
Languages : en
Pages : 486
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Book Description
The main purpose of this book is to encourage the proper implementation of the techniques which have contributed to Japan's industrial success. Designing for quality is the next evolutionary stage in quality systems, a stage that industries need to embrace.
Author: J. M. Juran
Publisher: Simon and Schuster
ISBN: 0029166837
Category : Business & Economics
Languages : en
Pages : 552
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Book Description
J.M. Juran, whom Business Week calls, "the man who taught Japan how to manage for quality", presents a new, exhaustively comprehensive approach to planning, setting, and reaching goals in Juran's Quality Road Map. New emphasis is placed on setting goals, planning in "multifunctional" processes, establishing data bases, motivating managers and introducing quality planning into organizations. 30 line drawings.
Author: Thomas B. Barker
Publisher: CRC Press
ISBN: 1482249677
Category : Business & Economics
Languages : en
Pages : 740
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Book Description
Achieve Technological Advancements in Applied Science and Engineering Using Efficient Experiments That Consume the Least Amount of ResourcesWritten by longtime experimental design guru Thomas B. Barker and experimental development/Six Sigma expert Andrew Milivojevich, Quality by Experimental Design, Fourth Edition shows how to design and analyze ex
Author: Grant Wiggins
Publisher: ASCD
ISBN: 1416613307
Category : Education
Languages : en
Pages : 139
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Book Description
The Understanding by Design Guide to Creating High-Quality Units offers instructional modules on the basic concepts and elements of Understanding by Design (UbD), the "backward design" approach used by thousands of educators to create curriculum units and assessments that focus on developing students' understanding of important ideas. The eight modules are organized around the UbD Template Version 2.0 and feature components similar to what is typically provided in a UbD design workshop, including— * Discussion and explanation of key ideas in the module; * Guiding exercises, worksheets, and design tips; * Examples of unit designs; * Review criteria with prompts for self-assessment; and * A list of resources for further information. This guide is intended for K-16 educators—either individuals or groups—who may have received some training in UbD and want to continue their work independently; those who've read Understanding by Design and want to design curriculum units but have no access to formal training; graduate and undergraduate students in university curriculum courses; and school and district administrators, curriculum directors, and others who facilitate UbD work with staff. Users can go through the modules in sequence or skip around, depending on their previous experience with UbD and their preferred curriculum design style or approach. Unit creation, planning, and adaptation are easier than ever with the accompanying downloadable resources, including the UbD template set up as a fillable PDF form, additional worksheets, examples, and FAQs about the module topics that speak to UbD novices and veterans alike.
Author: Eugene C. Nelson
Publisher: John Wiley & Sons
ISBN: 1118046838
Category : Medical
Languages : en
Pages : 507
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Book Description
Quality by Design reflects the research and applied training conducted at Dartmouth Medical School under the leadership of Gene Nelson, Paul Batalden, and Marjorie Godfrey. The book includes the research results of high-performing clinical microsystems, illustrative case studies that highlight individual clinical programs, guiding principles that are easily applied, and tools, techniques, and methods that can be adapted by clinical practices and interdisciplinary clinical teams. The authors describe how to develop microsystems that can attain peak performance through active engagement of interdisciplinary teams in learning and applying improvement science and measurement; explore the essence of leadership for clinical Microsystems; show what mid-level leaders can do to enable peak performance at the front lines of care; outline the design and redesign of services and planning care to match patient needs with services offered; examine the issue of safety; describe the vital role of data in creating a rich and useful information environment; provide a core curriculum that can build microsystems’ capability, provide excellent care, promote a positive work environment, and contribute to the larger organization. Ancillary materials for use in classroom teaching, training, or coaching are available at https://clinicalmicrosystem.org/
