Pharmaceutical Quality By Design Using Jmp Solving Product Development And Manufacturing Problems
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Pharmaceutical Quality By Design Using Jmp
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Author : Rob Lievense
language : en
Publisher: SAS Institute
Release Date : 2018-10-03
Pharmaceutical Quality By Design Using Jmp written by Rob Lievense and has been published by SAS Institute this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-10-03 with Computers categories.
Solve your pharmaceutical product development and manufacturing problems using JMP . Pharmaceutical Quality by Design Using JMP : Solving Product Development and Manufacturing Problems provides broad-based techniques available in JMP to visualize data and run statistical analyses for areas common in healthcare product manufacturing. As international regulatory agencies push the concept of Quality by Design (QbD), there is a growing emphasis to optimize the processing of products. This book uses practical examples from the pharmaceutical and medical device industries to illustrate easy-to-understand ways of incorporating QbD elements using JMP. Pharmaceutical Quality by Design Using JMP opens by demonstrating the easy navigation of JMP to visualize data through the distribution function and the graph builder and then highlights the following: the powerful dynamic nature of data visualization that enables users to be able to quickly extract meaningful information tools and techniques designed for the use of structured, multivariate sets of experiments examples of complex analysis unique to healthcare products such as particle size distributions/drug dissolution, stability of drug products over time, and blend uniformity/content uniformity. Scientists, engineers, and technicians involved throughout the pharmaceutical and medical device product life cycles will find this book invaluable. This book is part of the SAS Press program.
Discovering Partial Least Squares With Jmp
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Author : Ian Cox
language : en
Publisher: SAS Institute
Release Date : 2013-10
Discovering Partial Least Squares With Jmp written by Ian Cox and has been published by SAS Institute this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-10 with Computers categories.
Using JMP statistical discovery software from SAS, Discovering Partial Least Squares with JMP explores Partial Least Squares and positions it within the more general context of multivariate analysis. This book motivates current and potential users of JMP to extend their analytical repertoire by embracing PLS. Dynamically interacting with JMP, you will develop confidence as you explore underlying concepts and work through the examples. The authors provide background and guidance to support and empower you on this journey.
Statistical Thinking
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Author : Roger W. Hoerl
language : en
Publisher: John Wiley & Sons
Release Date : 2012-04-09
Statistical Thinking written by Roger W. Hoerl and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-04-09 with Business & Economics categories.
How statistical thinking and methodology can help you make crucial business decisions Straightforward and insightful, Statistical Thinking: Improving Business Performance, Second Edition, prepares you for business leadership by developing your capacity to apply statistical thinking to improve business processes. Unique and compelling, this book shows you how to derive actionable conclusions from data analysis, solve real problems, and improve real processes. Here, you'll discover how to implement statistical thinking and methodology in your work to improve business performance. Explores why statistical thinking is necessary and helpful Provides case studies that illustrate how to integrate several statistical tools into the decision-making process Facilitates and encourages an experiential learning environment to enable you to apply material to actual problems With an in-depth discussion of JMP® software, the new edition of this important book focuses on skills to improve business processes, including collecting data appropriate for a specified purpose, recognizing limitations in existing data, and understanding the limitations of statistical analyses.
Sustainable Manufacturing And Design
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Author : Kaushik Kumar
language : en
Publisher: Woodhead Publishing
Release Date : 2021-01-08
Sustainable Manufacturing And Design written by Kaushik Kumar and has been published by Woodhead Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-01-08 with Technology & Engineering categories.
Sustainable Manufacturing and Design draws together research and practices from a wide range of disciplines to help engineers design more environmentally sustainable products. Sustainable manufacturing requires that the entire manufacturing enterprise adopts sustainability goals at a system-level in decision-making, hence the scope of this book covers a wide range of viewpoints in response. Advice on recyclability, zero landfill design, sustainable quality systems, and product take-back issues make this a highly usable guide to the challenges facing engineering designers today. Contributions from around the globe are included, helping to form an international view of an issue that requires a global response. - Addresses methods to reduce energy and material waste through manufacturing design - Helps to troubleshoot manufacturability problems that can arise in sustainable design - Includes coverage of the legislative, cultural and social impacts of sustainable manufacturing, promoting a holistic view of the subject
Extenics And Innovation Methods
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Author : Wen Cai
language : en
Publisher: CRC Press
Release Date : 2013-07-15
Extenics And Innovation Methods written by Wen Cai and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-07-15 with Technology & Engineering categories.
Society forges ahead in the process of solving various contradictory problems and it is ceaselessly innovating. It is the desire of mankind to use computers and computing networks to help deal with contradictory problems and to conduct innovative activities. Using formal models to discuss object extension and the possibility of change, as well as the rules and methods for innovation, Extenics is applied to solving contradictory problems and has become the basic theory, method and instrument to achieve this goal. In the 30 years since the foundation of Extenics, researchers have built relatively complete theoretical systems —‘extension theory’, studied formal and modeling innovation methods —‘extension innovation methods’, and launched the applications in various fields such as information, design, automation and management etc. —‘extension engineering’. Extension theory, the extension innovation method and extension engineering jointly constitute the new discipline—Extenics. At the same time, the practical activities of engineering technology and management promote the integration of various innovation methods such as TRIZ and brainstorming etc. This book collects together, from scholars in various fields, the research achievements in Extenics and innovation methods, in order to facilitate and promote the development of Extenics and the various innovation theories and methods, as well as to improve its innovative capacity in academic and business circles.
Pharmaceutical Quality By Design
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Author : Walkiria S. Schlindwein
language : en
Publisher: John Wiley & Sons
Release Date : 2018-03-19
Pharmaceutical Quality By Design written by Walkiria S. Schlindwein and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-03-19 with Science categories.
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
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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
Development And Validation Of Analytical Methods
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Author : Christopher M. Riley
language : en
Publisher: Elsevier
Release Date : 1996-05-29
Development And Validation Of Analytical Methods written by Christopher M. Riley and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 1996-05-29 with Science categories.
The need to validate an analytical or bioanalytical method is encountered by analysts in the pharmaceutical industry on an almost daily basis, because adequately validated methods are a necessity for approvable regulatory filings. What constitutes a validated method, however, is subject to analyst interpretation because there is no universally accepted industry practice for assay validation. This book is intended to serve as a guide to the analyst in terms of the issues and parameters that must be considered in the development and validation of analytical methods. In addition to the critical issues surrounding method validation, this book also deals with other related factors such as method development, data acquisition, automation, cleaning validation and regulatory considerations. The book is divided into three parts. Part One, comprising two chapters, looks at some of the basic concepts of method validation. Chapter 1 discusses the general concept of validation and its role in the process of transferring methods from laboratory to laboratory. Chapter 2 looks at some of the critical parameters included in a validation program and the various statistical treatments given to these parameters.Part Two (Chapters 3, 4 and 5) of the book focuses on the regulatory perspective of analytical validation. Chapter 3 discusses in some detail how validation is treated by various regulatory agencies around the world, including the United States, Canada, the European Community, Australia and Japan. This chapter also discusses the International Conference on Harmonization (ICH) treatment of assay validation. Chapters 4 and 5 cover the issues and various perspectives of the recent United States vs. Barr Laboratories Inc. case involving the retesting of samples. Part Three (Chapters 6 - 12) covers the development and validation of various analytical components of the pharmaceutical product development process. This part of the book contains specific chapters dedicated to bulk drug substances and finished products, dissolution studies, robotics and automated workstations, biotechnology products, biological samples, analytical methods for cleaning procedures and computer systems and computer-aided validation. Each chapter goes into some detail describing the critical development and related validation considerations for each topic.This book is not intended to be a practical description of the analytical validation process, but more of a guide to the critical parameters and considerations that must be attended to in a pharmaceutical development program. Despite the existence of numerous guidelines including the recent attempts by the ICH to be implemented in 1998, the practical part of assay validation will always remain, to a certain extent, a matter of the personal preference of the analyst or company. Nevertheless, this book brings together the perspectives of several experts having extensive experience in different capacities in the pharmaceutical industry in an attempt to bring some consistency to analytical method development and validation.
Building Better Models With Jmp Pro
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Author : Jim Grayson
language : en
Publisher: SAS Institute
Release Date : 2015-08
Building Better Models With Jmp Pro written by Jim Grayson and has been published by SAS Institute this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-08 with Computers categories.
Explore the black box of business analytics and learn the methodology for managing and executing analytics projects.