Introduction To Quality By Design For Pharmaceuticals

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Pharmaceutical Quality by Design

Author : Walkiria S. Schlindwein
Publisher : John Wiley & Sons
ISBN 13 : 1118895215
Total Pages : 319 pages
Book Rating : 4.1/5 (188 download)

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Book Synopsis Pharmaceutical Quality by Design by : Walkiria S. Schlindwein

Download or read book Pharmaceutical Quality by Design written by Walkiria S. Schlindwein and published by John Wiley & Sons. This book was released on 2018-01-05 with total page 319 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Pharmaceutical Quality by Design

Author : Sarwar Beg
Publisher : Academic Press
ISBN 13 : 0128163720
Total Pages : 448 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Pharmaceutical Quality by Design by : Sarwar Beg

Download or read book Pharmaceutical Quality by Design written by Sarwar Beg and published by Academic Press. This book was released on 2019-03-27 with total page 448 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Pharmaceutical Quality by Design

Author : Walkiria S. Schlindwein
Publisher : John Wiley & Sons
ISBN 13 : 1118895207
Total Pages : 375 pages
Book Rating : 4.1/5 (188 download)

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Book Synopsis Pharmaceutical Quality by Design by : Walkiria S. Schlindwein

Download or read book Pharmaceutical Quality by Design written by Walkiria S. Schlindwein and published by John Wiley & Sons. This book was released on 2018-03-19 with total page 375 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Introduction to Quality by Design for Pharmaceuticals

Author : Nilesh Desai
Publisher : Pharmamed Press
ISBN 13 : 9789386819802
Total Pages : 192 pages
Book Rating : 4.8/5 (198 download)

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Book Synopsis Introduction to Quality by Design for Pharmaceuticals by : Nilesh Desai

Download or read book Introduction to Quality by Design for Pharmaceuticals written by Nilesh Desai and published by Pharmamed Press. This book was released on 2017-10-03 with total page 192 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quality by design (QbD) is extensively used tool in formulation and development. QbD is a method of choice in product development for robust and quality product incorporating continuous improvement. The objective of the book is to study the implementation of QbD and wide-ranging QbD based product development template for different formulations and analytical procedures. The way QbD is implemented in Pharmaceutical Industry, Academicians/ Institutes are way behind in this competition. The reason being, concepts of QbD are poorly explored byPharma Researchers due to nonexistence of expertise and resources. Researchers tend to adapt moderately the principles of QbD due to inadequate understanding of QbD principles. The use of QbD in formulation development will be advantageous to young researchers and academics.

Introduction to Quality by Design (QbD)

Author : N. K. Jain
Publisher : Springer Nature
ISBN 13 : 9819980348
Total Pages : 505 pages
Book Rating : 4.8/5 (199 download)

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Book Synopsis Introduction to Quality by Design (QbD) by : N. K. Jain

Download or read book Introduction to Quality by Design (QbD) written by N. K. Jain and published by Springer Nature. This book was released on with total page 505 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Quality by Design for Biopharmaceutical Drug Product Development

Author : Feroz Jameel
Publisher : Springer
ISBN 13 : 1493923161
Total Pages : 710 pages
Book Rating : 4.4/5 (939 download)

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Book Synopsis Quality by Design for Biopharmaceutical Drug Product Development by : Feroz Jameel

Download or read book Quality by Design for Biopharmaceutical Drug Product Development written by Feroz Jameel and published by Springer. This book was released on 2015-04-01 with total page 710 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key elements of QbD and examine how these elements are integrated into drug product development. These chapters also discuss lessons learned from the FDA Office of Biotechnology Products pilot program. Following chapters demonstrate how QbD is used for formulation development ranging from screening of formulations to developability assessment to development of lyophilized and liquid formats. The next few chapters study the use of small-scale and surrogate models as well as QbD application to drug product processes such as drug substance freezing and thawing, mixing, sterile filtration, filling, lyophilization, inspection and shipping and handling. Later chapters describe more specialized applications of QbD in the drug product realm. This includes the use of QbD in primary containers, devices and combination product development. The volume also explores QbD applied to vaccine development, automation, mathematical modeling and monitoring, and controlling processes and defining control strategies. It concludes with a discussion on the application of QbD to drug product technology transfer as well as overall regulatory considerations and lifecycle management. Quality by Design for Biopharmaceutical Drug Product Development is an authoritative resource for scientists and researchers interested in expanding their knowledge on QbD principles and uses in creating better drugs.

Introduction to Quality by Design in Pharmaceutical Manufacturing and Analytical Development

Author : Márcia Cristina Breitkreitz
Publisher : Springer Nature
ISBN 13 : 3031315057
Total Pages : 268 pages
Book Rating : 4.0/5 (313 download)

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Book Synopsis Introduction to Quality by Design in Pharmaceutical Manufacturing and Analytical Development by : Márcia Cristina Breitkreitz

Download or read book Introduction to Quality by Design in Pharmaceutical Manufacturing and Analytical Development written by Márcia Cristina Breitkreitz and published by Springer Nature. This book was released on 2023-07-13 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written by twenty-five authors from academia, pharmaceutical industry and Pharmacopeias worldwide, this monograph covers the fundamentals and applications of Quality by Design (QbD) and Analytical Quality by Design (AQbD) in a practical and didactic manner. The book starts by describing the motivation and the urgent need for the implementation of the QbD framework in pharmaceutical development, along with the definition of its major elements: Quality Target Product Profile (QTTP), Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), Critical Material Attributes (CMAs) and the importance of using multivariate methods of Design of Experiments (DOE). The concept of life cycle and regulatory perspectives are discussed. Three chapters are entirely dedicated to DOE theory from screening to optimization designs. Moreover, a comprehensive discussion on modelling and data treatment is presented. Practical aspects of QbD and DOE for pharmaceutical product and process of different dosage forms is included, as well as a practical guide of the input process variables, material attributes, intermediate, and final quality attributes for the most representative pharmaceutical processes. Analytical Quality by Design (AQbD) is also deeply explored, including risk analysis, definitions of Analytical Target Profile (ATP), Method Operable Design Region (MODR) and the life cycle approach, taking into account the compendial and regulatory perspectives. A detailed example of a new chromatographic method for the quality control of a pharmaceutical topical product based on the AQbD procedure is shown. Finally, advanced statistical approaches and DOE methods for extraction studies of bioactive compounds are also presented. The vast amount of information offered in this book provides a comprehensive perspective on QbD, AQbD and DOE principles, essential tools for modern pharmaceutical and analytical development.

Handbook of Analytical Quality by Design

Author : Sarwar Beg
Publisher : Academic Press
ISBN 13 : 0128203331
Total Pages : 225 pages
Book Rating : 4.1/5 (282 download)

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Book Synopsis Handbook of Analytical Quality by Design by : Sarwar Beg

Download or read book Handbook of Analytical Quality by Design written by Sarwar Beg and published by Academic Press. This book was released on 2021-01-09 with total page 225 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture

Author : Gintaras V. Reklaitis
Publisher : John Wiley & Sons
ISBN 13 : 0470942371
Total Pages : 418 pages
Book Rating : 4.4/5 (79 download)

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Book Synopsis Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture by : Gintaras V. Reklaitis

Download or read book Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture written by Gintaras V. Reklaitis and published by John Wiley & Sons. This book was released on 2017-10-09 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Author : Gintaras V. Reklaitis
Publisher : John Wiley & Sons
ISBN 13 : 1119356164
Total Pages : 420 pages
Book Rating : 4.1/5 (193 download)

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Book Synopsis Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture by : Gintaras V. Reklaitis

Download or read book Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture written by Gintaras V. Reklaitis and published by John Wiley & Sons. This book was released on 2017-08-30 with total page 420 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Quality by Design for Biopharmaceuticals

Author : Anurag S. Rathore
Publisher : John Wiley & Sons
ISBN 13 : 1118210913
Total Pages : 279 pages
Book Rating : 4.1/5 (182 download)

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Book Synopsis Quality by Design for Biopharmaceuticals by : Anurag S. Rathore

Download or read book Quality by Design for Biopharmaceuticals written by Anurag S. Rathore and published by John Wiley & Sons. This book was released on 2011-09-20 with total page 279 pages. Available in PDF, EPUB and Kindle. Book excerpt: The concepts, applications, and practical issues of Quality by Design Quality by Design (QbD) is a new framework currently being implemented by the FDA, as well as EU and Japanese regulatory agencies, to ensure better understanding of the process so as to yield a consistent and high-quality pharmaceutical product. QbD breaks from past approaches in assuming that drug quality cannot be tested into products; rather, it must be built into every step of the product creation process. Quality by Design: Perspectives and Case Studies presents the first systematic approach to QbD in the biotech industry. A comprehensive resource, it combines an in-depth explanation of basic concepts with real-life case studies that illustrate the practical aspects of QbD implementation. In this single source, leading authorities from the biotechnology industry and the FDA discuss such topics as: The understanding and development of the product's critical quality attributes (CQA) Development of the design space for a manufacturing process How to employ QbD to design a formulation process Raw material analysis and control strategy for QbD Process Analytical Technology (PAT) and how it relates to QbD Relevant PAT tools and applications for the pharmaceutical industry The uses of risk assessment and management in QbD Filing QbD information in regulatory documents The application of multivariate data analysis (MVDA) to QbD Filled with vivid case studies that illustrate QbD at work in companies today, Quality by Design is a core reference for scientists in the biopharmaceutical industry, regulatory agencies, and students.

Design and Manufacture of Pharmaceutical Tablets

Author : Reynir Eyjolfsson
Publisher : Academic Press
ISBN 13 : 012802187X
Total Pages : 68 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis Design and Manufacture of Pharmaceutical Tablets by : Reynir Eyjolfsson

Download or read book Design and Manufacture of Pharmaceutical Tablets written by Reynir Eyjolfsson and published by Academic Press. This book was released on 2014-10-09 with total page 68 pages. Available in PDF, EPUB and Kindle. Book excerpt: Design and Manufacture of Pharmaceutical Tablets offers real world solutions and outcomes of formulation and processing challenges of pharmaceutical tablets. This book includes numerous practical examples related to actual formulations that have been validated and marketed and covers important data in the areas of stability, dissolution, bioavailibity and processing. It provides important background and theoretical information on design and manufacturing and includes a full section dedicated to design experimental methodology and statistics. In addition, this book offers a a general discussion of excipients used in proper tablet design along with practical examples related to excipients. Drug development scientists in industry and academia, as well as students in the pharmaceutical sciences will greatly benefit from the practical knowledge and case examples provided throughout this book. Incorporates important mathematical models and computational applications Includes unique content on central composite design and augmented simplex lattice Provides background on important design principles with emphasis on quality-based design (QBD) of pharmaceutical dosage forms

Pharmaceutical Microbiological Quality Assurance and Control

Author : David Roesti
Publisher : John Wiley & Sons
ISBN 13 : 1119356075
Total Pages : 594 pages
Book Rating : 4.1/5 (193 download)

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Book Synopsis Pharmaceutical Microbiological Quality Assurance and Control by : David Roesti

Download or read book Pharmaceutical Microbiological Quality Assurance and Control written by David Roesti and published by John Wiley & Sons. This book was released on 2020-01-02 with total page 594 pages. Available in PDF, EPUB and Kindle. Book excerpt: Relying on practical examples from the authors’ experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks

Pharmaceutical Drug Product Development and Process Optimization

Author : Sarwar Beg
Publisher : CRC Press
ISBN 13 : 1000731324
Total Pages : 382 pages
Book Rating : 4.0/5 (7 download)

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Book Synopsis Pharmaceutical Drug Product Development and Process Optimization by : Sarwar Beg

Download or read book Pharmaceutical Drug Product Development and Process Optimization written by Sarwar Beg and published by CRC Press. This book was released on 2020-05-01 with total page 382 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical manufacturers are constantly facing quality crises of drug products, leading to an escalating number of product recalls and rejects. Due to the involvement of multiple factors, the goal of achieving consistent product quality is always a great challenge for pharmaceutical scientists. This volume addresses this challenge by using the Quality by Design (QbD) concept, which was instituted to focus on the systematic development of drug products with predefined objectives to provide enhanced product and process understanding. This volume presents and discusses the vital precepts underlying the efficient, effective, and cost effective development of pharmaceutical drug products. It focuses on the adoption of systematic quality principles of pharmaceutical development, which is imperative in achieving continuous improvement in end-product quality and also leads to reducing cost, time, and effort, while meeting regulatory requirements. The volume covers the important new advances in the development of solid oral dosage forms, modified release oral dosage forms, parenteral dosage forms, semisolid dosage forms, transdermal drug, delivery systems, inhalational dosage forms, ocular drug delivery systems, nanopharmaceutical products, and nanoparticles for oral delivery.

Pharmaceutical Process Design and Management

Author : Kate McCormick
Publisher : Routledge
ISBN 13 : 1317081404
Total Pages : 289 pages
Book Rating : 4.3/5 (17 download)

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Book Synopsis Pharmaceutical Process Design and Management by : Kate McCormick

Download or read book Pharmaceutical Process Design and Management written by Kate McCormick and published by Routledge. This book was released on 2016-04-22 with total page 289 pages. Available in PDF, EPUB and Kindle. Book excerpt: A quality product or service is the successful and profitable outcome of organising resources, as judged by the final customer. Every business unit needs processes in order to do this effectively; and all processes must be documented so that achievements can be measured and future improvements planned and implemented. Pharmaceutical Process Design and Management takes a step-wise approach to process management. It presents the various elements comprising a process (man, machine, materials, method and environment); it looks at quality control and quality assurance, tools for quality improvements and ways of structuring a process into discrete, fully accountable elements; it proposes that for processes to run successfully, all operators must be the initial problem-solvers; finally, it illustrates how, with the right tools, every problem can be broken down into solvable elements. Learn how to deploy a science and risk-based approach to pharmaceutical manufacturing, by taking a fundamental approach to process design and management and, as a consequence, keep your customers satisfied and your profits healthy.

ICH Quality Guidelines

Author : Andrew Teasdale
Publisher : John Wiley & Sons
ISBN 13 : 1118971124
Total Pages : 737 pages
Book Rating : 4.1/5 (189 download)

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Book Synopsis ICH Quality Guidelines by : Andrew Teasdale

Download or read book ICH Quality Guidelines written by Andrew Teasdale and published by John Wiley & Sons. This book was released on 2017-09-29 with total page 737 pages. Available in PDF, EPUB and Kindle. Book excerpt: Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. • Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies • Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines • Uses case studies to help readers understand and apply ICH guidelines • Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines • Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)

How to Integrate Quality by Efficient Design (QbED) in Product Development

Author : Bhavishya Mittal
Publisher : Academic Press
ISBN 13 : 0128173041
Total Pages : 274 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis How to Integrate Quality by Efficient Design (QbED) in Product Development by : Bhavishya Mittal

Download or read book How to Integrate Quality by Efficient Design (QbED) in Product Development written by Bhavishya Mittal and published by Academic Press. This book was released on 2019-08-24 with total page 274 pages. Available in PDF, EPUB and Kindle. 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