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Pharmaceutical Quality By Design Using Jmp

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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.

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 : Walkiria S. Schlindwein
language : en
Publisher: John Wiley & Sons
Release Date : 2018-01-11

Comprehensive Quality By Design For Pharmaceutical Product Development And Manufacture

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Author : Gintaras V. Reklaitis
language : en
Publisher: John Wiley & Sons
Release Date : 2017-08-30

Comprehensive Quality By Design For Pharmaceutical Product Development And Manufacture written by Gintaras V. Reklaitis 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 2017-08-30 with Science categories.

Covers a widespread view of Quality by Design (QbD) encompassing the many stages involved in the development of a new drug product. The book provides a broad view of Quality by Design (QbD) and shows how QbD concepts and analysis facilitate the development and manufacture of high quality products. QbD is seen as a framework for building process understanding, for implementing robust and effective manufacturing processes and provides the underpinnings for a science-based regulation of the pharmaceutical industry. Edited by the three renowned researchers in the field, Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture guides pharmaceutical engineers and scientists involved in product and process development, as well as teachers, on how to utilize QbD practices and applications effectively while complying with government regulations. The material is divided into three main sections: the first six chapters address the role of key technologies, including process modeling, process analytical technology, automated process control and statistical methodology in supporting QbD and establishing the associated design space. The second section consisting of seven chapters present a range of thoroughly developed case studies in which the tools and methodologies discussed in the first section are used to support specific drug substance and drug-product QbD related developments. The last section discussed the needs for integrated tools and reviews the status of information technology tools available for systematic data and knowledge management to support QbD and related activities. Highlights Demonstrates Quality by Design (QbD) concepts through concrete detailed industrial case studies involving of the use of best practices and assessment of regulatory implications Chapters are devoted to applications of QbD methodology in three main processing sectors—drug substance process development, oral drug product manufacture, parenteral product processing, and solid-liquid processing Reviews the spectrum of process model types and their relevance, the range of state-of-the-art real-time monitoring tools and chemometrics, and alternative automatic process control strategies and methods for both batch and continuous processes The role of the design space is demonstrated through specific examples and the importance of understanding the risk management aspects of design space definition is highlighted Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture is an ideal book for practitioners, researchers, and graduate students involved in the development, research, or studying of a new drug and its associated manufacturing process.

Computer Aided Pharmaceutics And Drug Delivery

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Author : Vikas Anand Saharan
language : en
Publisher: Springer Nature
Release Date : 2022-05-30

Computer Aided Pharmaceutics And Drug Delivery written by Vikas Anand Saharan and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-05-30 with Medical categories.

This book examines the role of computer-assisted techniques for discovering, designing, optimizing and manufacturing new, effective, and safe pharmaceutical formulations and drug delivery systems. The book discusses computational approaches, statistical modeling and molecular modeling for the development and safe delivery of drugs in humans. The application of concepts of QbD (Quality by Design), DoE (Design of Experiments), artificial intelligence and in silico pharmacokinetic assessment/simulation have been made a lot easier with the help of commercial software and expert systems. This title provides in-depth knowledge of such useful software with illustrations from the latest researches. The book also fills in the gap between pharmaceutics and molecular modeling at micro, meso and maro scale by covering topics such as advancements in computer-aided Drug Design (CADD), drug-polymer interactions in drug delivery systems, molecular modeling of nanoparticles and pharmaceutics/bioinformatics. This book provides abundant applications of computers in formulation designing and characterization are provided as examples, case studies and illustrations. Short reviews of software, databases and expert systems have also been added to culminate the interest of readers for novel applications in formulation development and drug delivery. Computer-aided pharmaceutics and drug delivery is an authoritative reference source for all the latest scholarly update on emerging developments in computed assisted techniques for drug designing and development. The book is ideally designed for pharmacists, medical practitioners, students and researchers.

Handbook Of Pharmaceutical Wet Granulation

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Author : Ajit S. Narang
language : en
Publisher: Academic Press
Release Date : 2018-08-31

Handbook Of Pharmaceutical Wet Granulation written by Ajit S. Narang and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-08-31 with Medical categories.

Handbook of Pharmaceutical Wet Granulation: Theory and Practice in a Quality by Design Paradigm offers a single and comprehensive reference dedicated to all aspects of pharmaceutical wet granulation, taking a holistic approach by combining introductory principles with practical solutions. Chapters are written by international experts across industry, academic and regulatory settings, and cover a wide spectrum of relevant and contemporary wet granulation topics, techniques and processes. The books' focus on process analytical technology, quality by design principles, granulation equipment, modeling, scale-up, control and real time release makes it a timely and valuable resource for all those involved in pharmaceutical wet granulation. - Discusses fundamentals of theory and current industrial practice in the field of wet granulation, including product and process design and role of material properties in wet granulation - Examines the modern evolution of wet granulation through current topics such as established and novel process analytical technologies (PATs), and product development and scale-up paradigms - Written for scientists working within the pharmaceutical industry, as well as academics, regulatory officials and equipment vendors who provide PAT tools and granulation equipment

Modern Industrial Statistics

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Author : Ron S. Kenett
language : en
Publisher: John Wiley & Sons
Release Date : 2021-05-10

Modern Industrial Statistics written by Ron S. Kenett 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 2021-05-10 with Mathematics categories.

Modern Industrial Statistics The new edition of the prime reference on the tools of statistics used in industry and services, integrating theoretical, practical, and computer-based approaches Modern Industrial Statistics is a leading reference and guide to the statistics tools widely used in industry and services. Designed to help professionals and students easily access relevant theoretical and practical information in a single volume, this standard resource employs a computer-intensive approach to industrial statistics and provides numerous examples and procedures in the popular R language and for MINITAB and JMP statistical analysis software. Divided into two parts, the text covers the principles of statistical thinking and analysis, bootstrapping, predictive analytics, Bayesian inference, time series analysis, acceptance sampling, statistical process control, design and analysis of experiments, simulation and computer experiments, and reliability and survival analysis. Part A, on computer age statistical analysis, can be used in general courses on analytics and statistics. Part B is focused on industrial statistics applications. The fully revised third edition covers the latest techniques in R, MINITAB and JMP, and features brand-new coverage of time series analysis, predictive analytics and Bayesian inference. New and expanded simulation activities, examples, and case studies—drawn from the electronics, metal work, pharmaceutical, and financial industries—are complemented by additional computer and modeling methods. Helping readers develop skills for modeling data and designing experiments, this comprehensive volume: Explains the use of computer-based methods such as bootstrapping and data visualization Covers nonstandard techniques and applications of industrial statistical process control (SPC) charts Contains numerous problems, exercises, and data sets representing real-life case studies of statistical work in various business and industry settings Includes access to a companion website that contains an introduction to R, sample R code, csv files of all data sets, JMP add-ins, and downloadable appendices Provides an author-created R package, mistat, that includes all data sets and statistical analysis applications used in the book Part of the acclaimed Statistics in Practice series, Modern Industrial Statistics with Applications in R, MINITAB, and JMP, Third Edition, is the perfect textbook for advanced undergraduate and postgraduate courses in the areas of industrial statistics, quality and reliability engineering, and an important reference for industrial statisticians, researchers, and practitioners in related fields. The mistat R-package is available from the R CRAN repository.

Method Validation In Pharmaceutical Analysis

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Author : Joachim Ermer
language : en
Publisher: John Wiley & Sons
Release Date : 2014-08-27

Method Validation In Pharmaceutical Analysis written by Joachim Ermer 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 2014-08-27 with Medical categories.

This second edition of a global bestseller has been completely redesigned and extensively rewritten to take into account the new Quality by Design (QbD) and lifecycle concepts in pharmaceutical manufacturing. As in the first edition, the fundamental requirements for analytical method validation are covered, but the second edition describes how these are applied systematically throughout the entire analytical lifecycle. QbD principles require adoption of a systematic approach to development and validation that begin with predefined objectives. For analytical methods these predefined objectives are established as an Analytical Target Profile (ATP). The book chapters are aligned with recently introduced standards and guidelines for manufacturing processes validation and follow the three stages of the analytical lifecycle: Method Design, Method Performance Qualification, and Continued Method Performance Verification. Case studies and examples from the pharmaceutical industry illustrate the concepts and guidelines presented, and the standards and regulations from the US (FDA), European (EMA) and global (ICH) regulatory authorities are considered throughout. The undisputed gold standard in the field.

Mastering Quality Assurance In Pharma A Comprehensive Guide To Cgmp Risk Management 2025

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Author : AUTHOR:1-Vamsi Krishna Gottipati, AUTHOR:2-Prof (Dr) Rakesh Kumar Dwivedi
language : en
Publisher: YASHITA PRAKASHAN PRIVATE LIMITED
Release Date :

Mastering Quality Assurance In Pharma A Comprehensive Guide To Cgmp Risk Management 2025 written by AUTHOR:1-Vamsi Krishna Gottipati, AUTHOR:2-Prof (Dr) Rakesh Kumar Dwivedi and has been published by YASHITA PRAKASHAN PRIVATE LIMITED this book supported file pdf, txt, epub, kindle and other format this book has been release on with Computers categories.

PREFACE In today’s hyperconnected world, the ability to integrate intelligent networking, stringent quality management, and resilient security measures has become a decisive competitive advantage. As organizations strive to innovate at pace, they face an intricate web of regulatory requirements, technological complexities, and evolving threat landscapes. This book is crafted to guide professionals through these intersecting domains—artificial intelligence in networking, pharmaceutical quality systems under global cGMP standards, and state-of-the-art infrastructure security—providing both conceptual frameworks and actionable insights. The journey begins with Chapter 1, which introduces the principles of AI-driven networking: from dynamic traffic optimization to self-healing network topologies. This foundation sets the stage for Chapters 2–4, where we delve into the world of pharmaceutical quality. We explored global cGMP requirements, methods for designing and maintaining a robust Quality Management System, and best practices for preserving documentation integrity and data trustworthiness. These chapters underscore that quality is not a static target but a continuously evolving process, driven by meticulous controls and unwavering compliance. Chapters 5 and 6 focus on Quality Risk Management—identifying, assessing, and mitigating risks across manufacturing operations. Real-world examples illustrate how risk-based decision-making reduces variability, enhances product safety, and fosters regulatory confidence. Chapter 7 then broadens the conversation into a comprehensive guide to cGMP and risk management, weaving together the theoretical underpinnings with hands-on strategies for audit readiness, change control, and corrective actions. Chapter 8 emphasizes quality control excellence, covering analytical method validation, in-process controls, and statistical quality tools that ensure every batch meets predetermined specifications. As technology reshapes traditional workflows, Chapter 9 examines digital transformation initiatives—cloud migration, data analytics, and IoT integration—that elevate quality management to new heights. In Chapter 10, we address the cultural and organizational dimensions of quality: leadership commitment, continuous training, and fostering a proactive, quality-first mindset that permeates every level of an enterprise. With the convergence of microservices and containerized environments, security is no longer an afterthought. Chapter 11 presents a deep dive into holistic security patterns for microservices: zero-trust architectures, service mesh encryption, policy enforcement engines, and automated drift detection. You’ll learn how to embed security throughout the development lifecycle, ensuring that every service-to-service interaction adheres to the highest standards of trust and integrity. Finally, Chapter 12 casts a forward-looking vision on infrastructure evolution: serverless platforms that eliminate operational overhead, edge computing that brings processing closer to data sources, autonomous systems that self-optimize, and the emerging trends that will define the next decade. Whether you are an IT architect, a quality assurance leader in the pharmaceutical industry, or a technology executive charting a digital transformation roadmap, this book equips you with the knowledge and tools to navigate complexity. By uniting AI-driven networking, rigorous quality systems, and resilient security frameworks, you will be prepared to achieve regulatory compliance, operational excellence, and sustainable innovation in an ever-changing landscape. Let this comprehensive guide serve as both a reference and a catalyst for your organization’s journey toward intelligent, secure, and quality-driven operations. Authors Vamsi Krishna Gottipati Prof (Dr) Rakesh Kumar Dwivedi

Optimal Design Of Experiments

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Author : Peter Goos
language : en
Publisher: John Wiley & Sons
Release Date : 2011-06-28

Optimal Design Of Experiments written by Peter Goos 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 2011-06-28 with Science categories.

"This is an engaging and informative book on the modern practice of experimental design. The authors' writing style is entertaining, the consulting dialogs are extremely enjoyable, and the technical material is presented brilliantly but not overwhelmingly. The book is a joy to read. Everyone who practices or teaches DOE should read this book." - Douglas C. Montgomery, Regents Professor, Department of Industrial Engineering, Arizona State University "It's been said: 'Design for the experiment, don't experiment for the design.' This book ably demonstrates this notion by showing how tailor-made, optimal designs can be effectively employed to meet a client's actual needs. It should be required reading for anyone interested in using the design of experiments in industrial settings." —Christopher J. Nachtsheim, Frank A Donaldson Chair in Operations Management, Carlson School of Management, University of Minnesota This book demonstrates the utility of the computer-aided optimal design approach using real industrial examples. These examples address questions such as the following: How can I do screening inexpensively if I have dozens of factors to investigate? What can I do if I have day-to-day variability and I can only perform 3 runs a day? How can I do RSM cost effectively if I have categorical factors? How can I design and analyze experiments when there is a factor that can only be changed a few times over the study? How can I include both ingredients in a mixture and processing factors in the same study? How can I design an experiment if there are many factor combinations that are impossible to run? How can I make sure that a time trend due to warming up of equipment does not affect the conclusions from a study? How can I take into account batch information in when designing experiments involving multiple batches? How can I add runs to a botched experiment to resolve ambiguities? While answering these questions the book also shows how to evaluate and compare designs. This allows researchers to make sensible trade-offs between the cost of experimentation and the amount of information they obtain.

Pharmaceutical Quality By Design Using Jmp

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