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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.
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.
This book is a structured approach to designing a product and its associated manufacturing process. It shows pharmaceutical engineers and scientists involved in product and process development how to utilize QbD practices and applications effectively while complying with government regulations. Material includes discussion of how to utilize design space, models, process control methodology, and cumulative process knowledge to seek improvements in manufacturing, while maintaining and enhancing product performance. Edited by three renowned researchers in the field, this invaluable resource is an essential tool for all pharmaceutical professionals.
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.
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
With a growing number of scientists and engineers using JMP software for design of experiments, there is a need for an example-driven book that supports the most widely used textbook on the subject, Design and Analysis of Experiments by Douglas C. Montgomery. Design and Analysis of Experiments by Douglas Montgomery: A Supplement for Using JMP meets this need and demonstrates all of the examples from the Montgomery text using JMP. In addition to scientists and engineers, undergraduate and graduate students will benefit greatly from this book. While users need to learn the theory, they also need to learn how to implement this theory efficiently on their academic projects and industry problems. In this first book of its kind using JMP software, Rushing, Karl and Wisnowski demonstrate how to design and analyze experiments for improving the quality, efficiency, and performance of working systems using JMP. Topics include JMP software, two-sample t-test, ANOVA, regression, design of experiments, blocking, factorial designs, fractional-factorial designs, central composite designs, Box-Behnken designs, split-plot designs, optimal designs, mixture designs, and 2 k factorial designs. JMP platforms used include Custom Design, Screening Design, Response Surface Design, Mixture Design, Distribution, Fit Y by X, Matched Pairs, Fit Model, and Profiler. With JMP software, Montgomery’s textbook, and Design and Analysis of Experiments by Douglas Montgomery: A Supplement for Using JMP, users will be able to fit the design to the problem, instead of fitting the problem to the design. This book is part of the SAS Press program.
Strategies for Formulations Development: A Step-by-Step Guide Using JMP is based on the authors' significant practical experience partnering with scientists to develop strategies to accelerate the formulation (mixtures) development process. The authors not only explain the most important methods used to design and analyze formulation experiments, but they also present overall strategies to enhance both the efficiency and effectiveness of the development process. With this book you will be able to: Approach the development process from a strategic viewpoint with the overall end result in mind. Design screening experiments to identify components that are most important to the performance of the formulation. Design optimization experiments to identify the maximum response in the design space. Analyze both screening and optimization experiments using graphical and numerical methods. Optimize multiple criteria, such as the quality, cost, and performance of product formulations. Design and analyze formulation studies that involve both formulation components and process variables using methods that reduce the required experimentation by up to 50%. Linking dynamic graphics with powerful statistics, JMP helps construct a visually compelling narrative to interactively share findings that are coherent and actionable by colleagues and decision makers. Using this book, you can take advantage of computer generated experiment designs when classical designs do not suffice, given the physical and economic constraints of the experiential environment. Strategies for Formulations Development: A Step-by-Step Guide Using JMP(R) is unique because it provides formulation scientists with the essential information they need in order to successfully conduct formulation studies in the chemical, biotech, and pharmaceutical industries.
A holistic, step-by-step approach to analyzing health care data! Written for both beginner and intermediate JMP users working in or studying health care, Data Management and Analysis Using JMP: Health Care Case Studies bridges the gap between taking traditional statistics courses and successfully applying statistical analysis in the workplace. Authors Jane Oppenlander and Patricia Schaffer begin by illustrating techniques to prepare data for analysis, followed by presenting effective methods to summarize, visualize, and analyze data. The statistical analysis methods covered in the book are the foundational techniques commonly applied to meet regulatory, operational, budgeting, and research needs in the health care field. This example-driven book shows practitioners how to solve real-world problems by using an approach that includes problem definition, data management, selecting the appropriate analysis methods, step-by-step JMP instructions, and interpreting statistical results in context. Practical strategies for selecting appropriate statistical methods, remediating data anomalies, and interpreting statistical results in the domain context are emphasized. The cases presented in Data Management and Analysis Using JMP use multiple statistical methods. A progression of methods--from univariate to multivariate--is employed, illustrating a logical approach to problem-solving. Much of the data used in these cases is open source and drawn from a variety of health care settings. The book offers a welcome guide to working professionals as well as students studying statistics in health care-related fields.
Lafler's book provides SAS users (Version 8.2) with a wonderful collection of tips, undocumented or hard-to-find tidbits of information, and other useful techniques in more than 1,000 entries.
Grasp the essentials of JMP to generate rapid results. JMP Essentials: An Illustrated Guide for New Users, Third Edition, is designed for new or novice JMP users who need to generate meaningful analysis quickly. The book focuses on the most commonly used platforms and typical workflow of the user, from data importing, exploring, and visualizing to modeling and sharing results with others. Throughout the book, the authors emphasize results over theory, providing just the essential steps with corresponding screenshots. In most cases, each section completes a JMP task, which maximizes the book’s utility as a reference. This edition has new instructions and screenshots reflecting the features added to the latest release of JMP software, including updated sections on JMP Dashboard Builder, Query Builder, the Fit Model platform, JMP Public and JMP Live, and a more detailed look at the JMP website. Each chapter contains a family of features that are carefully crafted to first introduce you to basic features and then move on to more advanced topics. JMP Essentials: An Illustrated Guide for New Users, Third Edition, is the quickest and most accessible reference book available.
This book examines statistical techniques that are critically important to Chemistry, Manufacturing, and Control (CMC) activities. Statistical methods are presented with a focus on applications unique to the CMC in the pharmaceutical industry. The target audience consists of statisticians and other scientists who are responsible for performing statistical analyses within a CMC environment. Basic statistical concepts are addressed in Chapter 2 followed by applications to specific topics related to development and manufacturing. The mathematical level assumes an elementary understanding of statistical methods. The ability to use Excel or statistical packages such as Minitab, JMP, SAS, or R will provide more value to the reader. The motivation for this book came from an American Association of Pharmaceutical Scientists (AAPS) short course on statistical methods applied to CMC applications presented by four of the authors. One of the course participants asked us for a good reference book, and the only book recommended was written over 20 years ago by Chow and Liu (1995). We agreed that a more recent book would serve a need in our industry. Since we began this project, an edited book has been published on the same topic by Zhang (2016). The chapters in Zhang discuss statistical methods for CMC as well as drug discovery and nonclinical development. We believe our book complements Zhang by providing more detailed statistical analyses and examples.
Learn how to improve the quality of health care offered by your institution using data you already have Improving Health Care Quality: Case Studies with JMP® teaches readers how to systematically identify problems, collect and interpret data, and solve issues in the real world. Relying on JMP® software, the authors walk readers through the process of applying quality improvement techniques to real-life health care problems. The case studies provided in the book vary significantly and provide a wide-ranging view of the application of quality improvement techniques in the health care field. Studies regarding length of stay of diabetes patients to benchmarking the costs of hip replacement all serve to illuminate and explain the underlying concepts of statistical analysis. The authors break each case study down into several sections, including: Background and Task Data and Data Management Analysis Summary Concepts and Tools Exercises and Discussion Questions Each section reinforces the lessons learned in each case study and helps the reader learn to apply statistical data to their own health care quality problems.

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