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Author: Bhavishya Mittal Publisher: Academic Press ISBN: 0128173041 Category : Business & Economics Languages : en Pages : 274
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: Bhavishya Mittal Publisher: Academic Press ISBN: 0128173041 Category : Business & Economics Languages : en Pages : 274
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: Sarwar Beg Publisher: Academic Press ISBN: 0128203331 Category : Business & Economics Languages : en Pages : 225
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: Igor Gorsky Publisher: Academic Press ISBN: 0128094125 Category : Medical Languages : en Pages : 298
Book Description
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
Author: Catalin Alexandru Publisher: BoD – Books on Demand ISBN: 1839682124 Category : Technology & Engineering Languages : en Pages : 168
Book Description
Product design is a comprehensive process related to the creation of new products, and the ability to design and develop efficient products are key to success in today’s dynamic global market. Written by experts in the field, this book provides a comprehensive overview of the product design process and its applications in various fields, particularly engineering. Over seven chapters, the authors explore such topics as development of new product design methodologies, implementation of effective methods for integrated products, development of more visualized environments for task-based conceptual design methods, and development of engineering design tools based on 3D photogrammetry, among others.
Author: Anil Mital Publisher: Elsevier ISBN: 0080556418 Category : Technology & Engineering Languages : en Pages : 448
Book Description
Today’s product development teams have to comprise an integrated group of professionals working from the very beginning of new product planning through design creation and design review and then on to manufacturing planning and cost accounting. More graduate and professional training programs are aimed at meeting that need by creating a better understanding of how to integrate and speed up the entire product development process. This book is the perfect accompaniment. This instructional reference work can be used in the traditional classroom, in professional continuing education courses or for self-study. This book has a ready audience among graduate students in mechanical and industrial engineering, as well as in many MBA programs focused on manufacturing management. This is a global need that will find a receptive readership in the industrialized world, particularly the rapidly developing industrial economies of South Asia and Southeast Asia. First text/reference to cover product development from initial product concept and engineering design to design specs, manufacturability and product marketing Reviews the precepts of Product design in a step-by-step structured process Helps the reader to understand the connection between initial design and interim and final design, including design review and materials selection Offers insight into roles played by product functionality, ease-of'assembly, maintenance and durability, and their interaction with cost estimation and manufacturability
Author: Ronald Mascitelli Publisher: Technology Perspectives ISBN: 096626973X Category : Industrial management Languages : en Pages : 324
Book Description
A practical guidebook for product development teams that describes proven tools and methods for slashing time-to-market for new products.
Author: Michael G. Luchs Publisher: John Wiley & Sons ISBN: 1118971809 Category : Business & Economics Languages : en Pages : 456
Book Description
Develop a more systematic, human-centered, results-oriented thought process Design Thinking is the Product Development and Management Association's (PDMA) guide to better problem solving and decision-making in product development and beyond. The second in the New Product Development Essentials series, this book shows you how to bridge the gap between the strategic importance of design and the tactical approach of design thinking. You'll learn how to approach new product development from a fresh perspective, with a focus on systematic, targeted thinking that results in a repeatable, human-centered problem-solving process. Integrating high-level discussion with practical, actionable strategy, this book helps you re-tool your thought processes in a way that translates well beyond product development, giving you a new way to approach business strategy and more. Design is a process of systematic creativity that yields the most appropriate solution to a properly identified problem. Design thinking disrupts stalemates and brings logic to the forefront of the conversation. This book shows you how to adopt these techniques and train your brain to see the answer to any question, at any level, in any stage of the development process. Become a better problem-solver in every aspect of business Connect strategy with practice in the context of product development Systematically map out your new product, service, or business Experiment with new thought processes and decision making strategies You can't rely on old ways of thinking to produce the newest, most cutting-edge solutions. Product development is the bedrock of business —whether your "product" is a tangible object, a service, or the business itself — and your approach must be consistently and reliably productive. Design Thinking helps you internalize this essential process so you can bring value to innovation and merge strategy with reality.
Author: Ben Wang Publisher: Springer Science & Business Media ISBN: 1461563836 Category : Technology & Engineering Languages : en Pages : 505
Book Description
The need exists in the private sector and government manufacturing sites to reduce product development time, production lead times, inventory, and non-value added activities. At the same time, there is increased pressure to improve manufacturing process yields, produc tion efficiency, and resource utilization. Much of the technology required to meet these needs already exists, but an integrated structure that can demonstrate the potential for the technology in a concurrent engineering context does not. This book provides a road map for building the integrated technology environment to evaluate existing products, manufacturing processes and system design tools. This book details innovative approaches that will significantly improve design/manufacturing technology development and deploy ment capabilities for civilian and defense applications. These approaches are integrated product, process, and system design (IPPSD) initiatives which will greatly enhance the manufacturing competitiveness of the economy. These approaches involve the use of simulation, modeling tools and computerized virtual workstations in conjunction with a design environment which allows a diverse group of researchers, manufacturers, and suppliers to work within a comprehensive network of shared knowledge. The IPPSD infrastructure consists of virtual workstations, servers and a suite of simulation, quantitative, computa tional, analytical, experimental and qualitative tools. Such an IPPSD infrastructure will permit effective and efficient predictions of complete product design, manufacturing proces design, and customer satisfac tion.
Author: Christopher Mattson Publisher: ISBN: 9781974606320 Category : Languages : en Pages : 362
Book Description
Great products come from great designers using great development processes. But how does a novice designer become a great designer? And how does an ordinary development process become a great development process? Fundamentals of Product Development explores the evolution of products from the beginning idea through mass-production. Rather than prescribing a one-size-fits-all process, it explores the theory behind product development and challenges readers to develop their own customized development process that is uniquely suited for their individual situation. In addition to theory, the book provides development case studies and a product development reference that introduces a wide variety of design tools and methods. In this 5th edition, the authors have increased the detail in the activity maps presented for each stage of development. These maps help novice development teams navigate the challenges of each stage, and remind experienced teams of activities and outcomes that should not be overlooked.Also included in this edition are new development reference entries on cost estimation and targets, design reviews, multivoting, optimization, revision control, and storyboards.
Author: Kai Yang Publisher: McGraw Hill Professional ISBN: 9780071547680 Category : Business & Economics Languages : en Pages : 741
Book Description
The Latest Tools and Guidance Needed to Implement Design for Six Sigma in New Product and Service Development! Hailed as a classic in its first edition, Design for Six Sigma has been fully revised and updated to equip you with everything you need to implement Design for Six Sigma (DFSS) in new product and service development. The Second Edition of this indispensable design tool retains the core of the previous edition, while adding new information on innovation, lean product development, incomplete DOE, mixture experiments, and alternative DFSS roadmaps—plus new thread-through case studies. From quality concepts and DFSS fundamentals...to DFSS deployment and project algorithm...to design validation, the updated edition of Design for Six Sigma gives you a solid understanding of the entire process for applying DFSS in the creation of successful new products and services. Packed with detailed illustrations, careful directions and comparisons, and worked-out calculations, the Second Edition of Design for Six Sigma features: A one-stop resource for developing a sure-fire DFSS program Expert walkthroughs that help readers choose the right design tools at every stage of the DFSS process New to this edition: new chapters on innovation, lean product development, and computer simulation; new material on critical parameter management; new thread-through case studies Providing real-world product development experience and insight throughout, the Second Edition of Design for Six Sigma now offers professionals in a wide range of industries the information required to maximize DFSS potential in creating winning products and services for today's marketplace. Filled with over 200 detailed illustrations, the Second Edition of Design for Six Sigma first gives you a solid foundation in quality concepts, Six Sigma fundamentals, and the nature of Design for Six Sigma, and then presents clear, step-by-step coverage of: Design for Six Sigma Deployment Design for Six Sigma Project Algorithm DFSS Transfer Function and Scorecards Quality Function Deployment (QFD) Axiomatic Design Innovation in Product Design Lean Product Development TRIZ Design for X Failure Mode-Effect Analysis Fundamentals of Experimental Design Incomplete DOE Taguchi's Orthogonal Array Experiment Taguchi's Robust Parameter Design Tolerance Design Response Surface Methodology Mixture Experiments Design Validation
Author: Bhavishya Mittal
Author: Bhavishya Mittal
Author: Sarwar Beg
Author: Igor Gorsky
Author: Catalin Alexandru
Author: Anil Mital
Author: Ronald Mascitelli
Author: Michael G. Luchs
Author: Ben Wang
Author: Christopher Mattson
Author: Kai Yang