How To Integrate Quality By Efficient Design Qbed In Product Development
DOWNLOAD
Download How To Integrate Quality By Efficient Design Qbed In Product Development PDF/ePub or read online books in Mobi eBooks. Click Download or Read Online button to get How To Integrate Quality By Efficient Design Qbed In Product Development book now. This website allows unlimited access to, at the time of writing, more than 1.5 million titles, including hundreds of thousands of titles in various foreign languages. If the content not found or just blank you must refresh this page
How To Integrate Quality By Efficient Design Qbed In Product Development
DOWNLOAD
Author : Bhavishya Mittal
language : en
Publisher: Academic Press
Release Date : 2019-08-24
How To Integrate Quality By Efficient Design Qbed In Product Development written by Bhavishya Mittal and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-08-24 with Medical categories.
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
DOWNLOAD
Author : Sarwar Beg
language : en
Publisher: Academic Press
Release Date : 2021-01-09
Handbook Of Analytical Quality By Design written by Sarwar Beg and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-01-09 with Science categories.
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
Sustainable Global Health Systems And Pharmaceutical Development
DOWNLOAD
Author : Bhavishya Mittal
language : en
Publisher: Springer Nature
Release Date : 2024-09-02
Sustainable Global Health Systems And Pharmaceutical Development written by Bhavishya Mittal and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-09-02 with Medical categories.
Strategic decision-making focusing on economics is the fundamental requirement to generate efficiency and improve productivity in any manufacturing environment. In the 21st century, the science of drug development is an established field that requires a dedicated and synergistic partnership between various subject matter experts. Unfortunately, pharmaceutical research is complicated, time-consuming, attritive, and costly, with development costs ranging from $4 billion to $11 billion per commercialized drug. There are more than 750 biotech and big pharma companies in the US that are developing new drug products for a vast number of therapeutic indications. Due to the high attrition rate in clinical trials, a small percentage of these drugs get commercialized. Still, a very high amount of resources are being spent on drug development from a societal perspective. Despite being an economically intense activity, the current state of drug product development makes a limited effort to integrate economics into product design and development. For example, pharmaceutical scientists are excellent at a data-driven decision-making process that requires technical elements and a few strategic elements. However, there is minimal integration of financial valuation elements (commonly employed in other high-tech industries such as fine chemicals, automotive, aerospace, etc.) into pharmaceutical drug development. Unfortunately, this hurts the sustainability of the health system of which these products will be a part in the future. A desirable future state integrates fundamentals of economics in product design and development so that the decision-making is parameterized, the cost of goods can be lowered, wastage can be reduced, patient-centricity is built into the design, and manufacturing/distribution efficiencies can be gained. The financial benefits of such an approach could allow for these savings to be passed on to the stakeholders and improve the value proposition of pharmaceuticals, which is critical to maintaining the innovation potential. This book hopes to introduce the reader to this desired future state of pharmaceutical drug development.
Principles Of Parenteral Solution Validation
DOWNLOAD
Author : Igor Gorsky
language : en
Publisher: Academic Press
Release Date : 2019-11-27
Principles Of Parenteral Solution Validation written by Igor Gorsky and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-11-27 with Medical categories.
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
Design For Six Sigma
DOWNLOAD
Author : Elizabeth A. Cudney
language : en
Publisher: CRC Press
Release Date : 2016-08-05
Design For Six Sigma written by Elizabeth A. Cudney and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-08-05 with Technology & Engineering categories.
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 needs by understanding their requirements, considering current process capability, identifying and reducing gaps, and verifying predictions to develop a robust design. This book offers: Methodology on how to implement DFSS in various industries Practical examples of the use of DFSS Sustainability utilizing Lean Six Sigma techniques and Lean product development Innovative designs using DFSS with concept generation Case studies for implementing the DFSS methodology Design for Six Sigma (DFSS) enables organizations to develop innovative designs. In order to redesign an existing process or design a new process, the success is dependent on a rigorous process and methodology. DFSS ensures that there are minimal defects in the introduction of new products, processes, or services. The authors have compiled all of the tools necessary for implementation of a practical approach though innovation.
Advances In Pharmaceutical Product Development
DOWNLOAD
Author : Keerti Jain
language : en
Publisher: Springer Nature
Release Date : 2025-03-18
Advances In Pharmaceutical Product Development written by Keerti Jain and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2025-03-18 with Medical categories.
This book discusses the stages involved in pharmaceutical product development including the importance, requirement, and effect of each stage and process. It also covers prototype development for pharmaceutical formulations, scale-up studies, optimization, testing, packaging, and commercialization of different dosage forms for pharmaceutical products like tablets, suspensions, emulsions, coating, inhalational products, sterile products, and herbal formulations. The book also presents advancements in tablet production and tablet coating, including materials, material handling, granulation and granulation technologies, process automation, processing problems in tablet production and troubleshooting, advances in equipment for coating and coating materials. Further, the chapter explores the advances in the formulation and development of aerosols, nebulizers, inhalers, metered Dose Inhalers (MDI), and dry powder Inhalers (DPIs). Towards the end, the book examines the challenges, formulation development, testing, stability, and regulatory guidelines in the development of herbal formulations. This book provides a valuable source of information for the researcher, scientists, students, and people working in the area mainly focused on the challenges in pharmaceutical product development.
Revolutionizing Product Development
DOWNLOAD
Author : Steven C. Wheelwright
language : en
Publisher: Simon and Schuster
Release Date : 1992-06-15
Revolutionizing Product Development written by Steven C. Wheelwright and has been published by Simon and Schuster this book supported file pdf, txt, epub, kindle and other format this book has been release on 1992-06-15 with Business & Economics categories.
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.
Miscellaneous Publication
DOWNLOAD
Author :
language : en
Publisher:
Release Date : 1981
Miscellaneous Publication written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1981 with Agriculture categories.
Developing Solid Oral Dosage Forms
DOWNLOAD
Author : Yihong Qiu
language : en
Publisher: Academic Press
Release Date : 2016-11-08
Developing Solid Oral Dosage Forms written by Yihong Qiu and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-11-08 with Medical categories.
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
Pharmaceutical Quality By Design
DOWNLOAD
Author : Sarwar Beg
language : en
Publisher: Academic Press
Release Date : 2019-03-27
Pharmaceutical Quality By Design written by Sarwar Beg and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-03-27 with Medical categories.
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