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Author: Rob Lievense
Publisher: SAS Institute
ISBN: 1635266181
Category : Computers
Languages : en
Pages : 567
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Book Description
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.
Author: Rob Lievense
Publisher: SAS Institute
ISBN: 1635266181
Category : Computers
Languages : en
Pages : 567
Get Book Here
Book Description
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.
Author: Walkiria S. Schlindwein
Publisher: John Wiley & Sons
ISBN: 1118895215
Category : Science
Languages : en
Pages : 319
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Book Description
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.
Author: Kamil Nicieja
Publisher: Simon and Schuster
ISBN: 1638353905
Category : Computers
Languages : en
Pages : 470
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Book Description
Summary Writing Great Specifications is an example-rich tutorial that teaches you how to write good Gherkin specification documents that take advantage of the benefits of specification by example. Foreword written by Gojko Adzic. Purchase of the print book includes a free eBook in PDF, Kindle, and ePub formats from Manning Publications. About the Technology The clearest way to communicate a software specification is to provide examples of how it should work. Turning these story-based descriptions into a well-organized dev plan is another matter. Gherkin is a human-friendly, jargon-free language for documenting a suite of examples as an executable specification. It fosters efficient collaboration between business and dev teams, and it's an excellent foundation for the specification by example (SBE) process. About the Book Writing Great Specifications teaches you how to capture executable software designs in Gherkin following the SBE method. Written for both developers and non-technical team members, this practical book starts with collecting individual feature stories and organizing them into a full, testable spec. You'll learn to choose the best scenarios, write them in a way that anyone can understand, and ensure they can be easily updated by anyone.management. What's Inside Reading and writing Gherkin Designing story-based test cases Team Collaboration Managing a suite of Gherkin documents About the Reader Primarily written for developers and architects, this book is accessible to any member of a software design team. About the Author Kamil Nicieja is a seasoned engineer, architect, and project manager with deep expertise in Gherkin and SBE. Table of contents Introduction to specification by example and Gherkin PART 1 - WRITING EXECUTABLE SPECIFICATIONS WITH EXAMPLES The specification layer and the automation layer Mastering the Given-When-Then template The basics of scenario outlines Choosing examples for scenario outlines The life cycle of executable specifications Living documentation PART 2 - MANAGING SPECIFICATION SUITES Organizing scenarios into a specification suite Refactoring features into abilities and business needs Building a domain-driven specification suite Managing large projects with bounded contexts
Author: Sarwar Beg
Publisher: Academic Press
ISBN: 0128163720
Category : Medical
Languages : en
Pages : 450
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Book Description
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
Author: Roger W. Hoerl
Publisher: John Wiley & Sons
ISBN: 1118236858
Category : Business & Economics
Languages : en
Pages : 544
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Book Description
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.
Author: Feroz Jameel
Publisher: Springer
ISBN: 1493923161
Category : Medical
Languages : en
Pages : 710
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Book Description
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.
Author: Christopher M. Riley
Publisher: Elsevier
ISBN: 0080530354
Category : Science
Languages : en
Pages : 363
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Book Description
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.
Author: Jim Grayson
Publisher: SAS Institute
ISBN: 1629599565
Category : Computers
Languages : en
Pages : 375
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Book Description
Building Better Models with JMP® Pro provides an example-based introduction to business analytics, with a proven process that guides you in the application of modeling tools and concepts. It gives you the "what, why, and how" of using JMP® Pro for building and applying analytic models. This book is designed for business analysts, managers, and practitioners who may not have a solid statistical background, but need to be able to readily apply analytic methods to solve business problems. In addition, this book will greatly benefit faculty members who teach any of the following subjects at the lower to upper graduate level: predictive modeling, data mining, and business analytics. Novice to advanced users in business statistics, business analytics, and predictive modeling will find that it provides a peek inside the black box of algorithms and the methods used. Topics include: regression, logistic regression, classification and regression trees, neural networks, model cross-validation, model comparison and selection, and data reduction techniques. Full of rich examples, Building Better Models with JMP Pro is an applied book on business analytics and modeling that introduces a simple methodology for managing and executing analytics projects. No prior experience with JMP is needed. Make more informed decisions from your data using this newest JMP book.
Author: Ajit S Narang
Publisher: Springer
ISBN: 3319202065
Category : Medical
Languages : en
Pages : 700
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Book Description
In recent years, emerging trends in the design and development of drug products have indicated ever greater need for integrated characterization of excipients and in-depth understanding of their roles in drug delivery applications. This book presents a concise summary of relevant scientific and mechanistic information that can aid the use of excipients in formulation design and drug delivery applications. Each chapter is contributed by chosen experts in their respective fields, which affords truly in-depth perspective into a spectrum of excipient-focused topics. This book captures current subjects of interest – with the most up to date research updates – in the field of pharmaceutical excipients. This includes areas of interest to the biopharmaceutical industry users, students, educators, excipient manufacturers, and regulatory bodies alike.
Author: Karl T. Ulrich
Publisher: Irwin/McGraw-Hill
ISBN:
Category : Business & Economics
Languages : en
Pages : 392
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Book Description
This text presents a set of product development techniques aimed at bringing together the marketing, design, and manufacturing functions of the enterprise. The integrative methods facilitate problem-solving and decision-making.
