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
Publsiher: Academic Press
Total Pages: 274
Release: 2019-08-24
Genre: Business & Economics
ISBN: 9780128173046

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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

Handbook of Analytical Quality by Design

Handbook of Analytical Quality by Design
Author: Sarwar Beg,Md Saquib Hasnain,Mahfoozur Rahman,Waleed H. Almalki
Publsiher: Academic Press
Total Pages: 222
Release: 2021-01-09
Genre: Business & Economics
ISBN: 9780128203330

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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 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

Principles of Parenteral Solution Validation

Principles of Parenteral Solution Validation
Author: Igor Gorsky,Harold S. Baseman
Publsiher: Academic Press
Total Pages: 298
Release: 2019-11-27
Genre: Medical
ISBN: 9780128094464

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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 facing practitioners in this area. Discusses international and domestic regulatory considerations in every section Features callout boxes that contain points-of-interest for each segment of the audience so readers can quickly find their interests and needs Contains important topics, including risk management, the preparation and execution of properly designed studies, scale-up and technology transfer activities, problem-solving, and more

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
Publsiher: John Wiley & Sons
Total Pages: 416
Release: 2017-09-01
Genre: Science
ISBN: 9781119356172

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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 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.

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
Publsiher: John Wiley & Sons
Total Pages: 416
Release: 2017-08-30
Genre: Science
ISBN: 9781119356165

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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 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.

Developing Solid Oral Dosage Forms

Developing Solid Oral Dosage Forms
Author: Yihong Qiu,Yisheng Chen,Geoff G.Z. Zhang,Lawrence Yu,Rao V. Mantri
Publsiher: Academic Press
Total Pages: 1176
Release: 2016-11-08
Genre: Medical
ISBN: 9780128026373

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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, 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 a comprehensive, well-organized, valuable reference for industry professionals and academics engaged in all aspects of the development process. New and important topics include spray drying, amorphous solid dispersion using hot-melt extrusion, modeling and simulation, bioequivalence of complex modified-released dosage forms, biowaivers, and much more. Written and edited by an international team of leading experts with experience and knowledge across industry, academia, and regulatory settings Includes new chapters covering the pharmaceutical applications of surface phenomenon, predictive biopharmaceutics and pharmacokinetics, the development of formulations for drug discovery support, and much more Presents new case studies throughout, and a section completely devoted to regulatory aspects, including global product regulation and international perspectives

Revolutionizing Product Development

Revolutionizing Product Development
Author: Steven C. Wheelwright,Kim B. Clark
Publsiher: Simon and Schuster
Total Pages: 364
Release: 1992-06-15
Genre: Business & Economics
ISBN: 9780029055151

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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 authors argue that to survive, let alone succeed, today's companies must construct a new "platform" -- with new methodologies -- on which they can compete. Using their model for development strategies, Wheelwright and Clark show that firms can create a solid architecture for the integration of marketing, manufacturing, and design functions for problem solving and fast action -- particularly during the critical design-build-test cycles of prototype creation. They demonstrate further how successful firms such as Honda in automobiles, Compaq in personal computers, Applied Materials in semi-conductors, Sony in audio equipment, The Limited in apparel, and Hill-Rom in hospital beds have employed recent methodologies to bring new products to market at break-neck speed. Such innovations include design for manufacturability, quality function deployment, computer-aided design, and computer-aided engineering. Finally, Wheelwright and Clark emphasize the importance of learning in the organization. Companies that consistently "design it right the first time" and follow a path of continuous improvement in product and process development have a formidable edge in the crucial race to market.

Design of Experiments for Pharmaceutical Product Development

Design of Experiments for Pharmaceutical Product Development
Author: Sarwar Beg
Publsiher: Springer Nature
Total Pages: 96
Release: 2021-01-12
Genre: Medical
ISBN: 9789813347175

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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 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 and postgraduate research scholars, pharmacists, biostatisticians, biotechnologists, formulations and process engineers, regulatory affairs and quality assurance personnel.

How to Develop Robust Solid Oral Dosage Forms

How to Develop Robust Solid Oral Dosage Forms
Author: Bhavishya Mittal
Publsiher: Academic Press
Total Pages: 190
Release: 2016-10-05
Genre: Medical
ISBN: 9780128047323

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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 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 at the key aspects in the development of solid oral dosage forms. Focuses on important topics, such as robustness, bioavailability, formulation design, continuous processing, stability tests, modified release dosage forms, international guidelines, process scale-up, and much more Part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin Discusses common, real-world problems and offers both theoretical and practical solutions to these everyday issues

Formulation and Analytical Development for Low Dose Oral Drug Products

Formulation and Analytical Development for Low Dose Oral Drug Products
Author: Jack Zheng
Publsiher: John Wiley & Sons
Total Pages: 496
Release: 2009-02-09
Genre: Medical
ISBN: 9780470056097

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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 pharmaceutical scientists, regulators, and graduate students.

Computer aided applications in pharmaceutical technology

Computer aided applications in pharmaceutical technology
Author: Jelena Djuris,Svetlana Ibric,Zorica Djuric
Publsiher: Elsevier Inc. Chapters
Total Pages: 300
Release: 2013-04-10
Genre: Technology & Engineering
ISBN: 9780128091876

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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 is presented from both regulatory and manufacturers’ points of view. Several illustrative examples are provided to facilitate the understanding of the QbD concept and ease of its application.

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
Publsiher: CRC Press
Total Pages: 624
Release: 2005-01-20
Genre: Technology & Engineering
ISBN: 0415366097

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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 four years’ work of the cooperative, but also the contributions made by other international experts at the conference, focused on three broad themes: mixed building technology; structural integrity under exceptional actions; and urban design.

Setting the PACE in Product Development

Setting the PACE in Product Development
Author: Michael E. McGrath
Publsiher: Routledge
Total Pages: 184
Release: 1996
Genre: Technology & Engineering
ISBN: 9780750697897

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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 in paperback with 3 new chapters on product strategy, technology management and cross-project management. Popular proven method of success for achieving efficiency in product development and cycle time. A must for anyone who needs quality results in a timely fashion.

Textile Technology Digest

Textile Technology Digest
Author: Anonim
Publsiher: Unknown
Total Pages: 135
Release: 2000
Genre: Textile fabrics
ISBN: CORNELL:31924089488948

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Design of Experiments for Pharmaceutical Product Development

Design of Experiments for Pharmaceutical Product Development
Author: Sarwar Beg
Publsiher: Springer Nature
Total Pages: 188
Release: 2021-01-22
Genre: Medical
ISBN: 9789813343511

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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 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 and postgraduate research scholars, pharmacists, biostatisticians, biotechnologists, formulations and process engineers, regulatory affairs and quality assurance personnel.