Quality Control Applications in the Pharmaceutical and Medical Device Manufacturing Industry, Carrillo-Cedillo Eugenia Gabriela, Arredondo-Soto Karina Cecilia, Palomino-Vizcaino Kenia
Описание: 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.
Biopharmaceuticals, medicines made by or from living organisms (including cells from living organisms), are extremely effective in treating a broad range of diseases. Their importance to human health has grown significantly over the years as more biopharmaceutical products have entered the market, and now the biggest selling drugs in the world are biopharmaceuticals. Biopharmaceutical Manufacturing: Principles, Processes and Practices provides concise, comprehensive, and up-to-date coverage of biopharmaceutical manufacturing. Written in a clear and informal style, the content has been influenced by the authors’ substantial industry experience and teaching expertise. That expertise enables the authors to address the many questions posed over the years both by university students and professionals with experience in the field. Consequently, the book will appeal both to undergraduate or graduate students using it as a textbook and specialized industry practitioners seeking to understand the big picture of biopharmaceutical manufacturing. This book:
Описание: Illustrates the use of systems such as in-process control, quality auditing, and specifications, stressing a troubleshooting, cost-effective approach to product packaging for maximized early lead time to the customer. Addressing the needs of the pharmaceutical industry, the approaches supplied are l
Автор: S.G. Ponnambalam, Nachiappan Subramanian, Manoj Kumar Tiwari, Wan Azhar Wan Yusoff Название: Industry 4.0 and Hyper-Customized Smart Manufacturing Supply Chains ISBN: 152259079X ISBN-13(EAN): 9781522590798 Издательство: Mare Nostrum (Eurospan) Цена: 24948.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Next-generation supply chains revolve around smart manufacturing processes and personalized customization of products and services. For businesses to stay relevant in the market today, prioritizing customer satisfaction with speed and great service has become crucial. Industry 4.0 and Hyper-Customized Smart Manufacturing Supply Chains is an assemblage of innovative research ideas surrounding the methods of modern smart manufacturing technologies and digital supply chain management in the era of Industry 4.0. While highlighting topics including blockchain diffusion, logistics system, and data analytics, this book is ideally designed for industry professionals, researchers, managers, and students seeking current research on the role of technology in business production.
Автор: Ponnambalam S. G., Subramanian Nachiappan, Tiwari Manoj Kumar Название: Industry 4.0 and Hyper-Customized Smart Manufacturing Supply Chains ISBN: 1522590781 ISBN-13(EAN): 9781522590781 Издательство: Mare Nostrum (Eurospan) Рейтинг: Цена: 32987.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Next-generation supply chains revolve around smart manufacturing processes and personalized customization of products and services. For businesses to stay relevant in the market today, prioritizing customer satisfaction with speed and great service has become crucial. Industry 4.0 and Hyper-Customized Smart Manufacturing Supply Chains is an assemblage of innovative research ideas surrounding the methods of modern smart manufacturing technologies and digital supply chain management in the era of Industry 4.0. While highlighting topics including blockchain diffusion, logistics system, and data analytics, this book is ideally designed for industry professionals, researchers, managers, and students seeking current research on the role of technology in business production.
Название: Good Manufacturing Practices Pharma ISBN: 1498732062 ISBN-13(EAN): 9781498732062 Издательство: Taylor&Francis Рейтинг: Цена: 26796.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting. Chapter flow has been changed to adopt a quality systems organization approach, and supporting chapters have been updated based on current hot topics including the impact of the worldwide supply chain complexity and current regulatory trends.
Key Features:
Presents insight into the world of pharmaceutical quality systems
Analyzes regulatory trends and expectations
Includes approaches and practices used in the industry to comply with regulatory requirements
Discusses recent worldwide supply chain issues
Delivers valuable information to a worldwide audience regarding the current GMP practices in the industry
Автор: Cavalla David Название: Drug Repurposing ISBN: 1788019032 ISBN-13(EAN): 9781788019033 Издательство: Royal Society of Chemistry Рейтинг: Цена: 45923.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Drug Repurposing provides an ideal introduction to the field of drug repositioning and repurposing with contributions from world-renowned experts culminating in an excellent resource for any drug discovery or medicinal chemist.
Описание: Physiologically-Based Pharmacokinetic (PBPK) Modeling and Simulations
The first book dedicated to the emerging field of physiologically-based pharmacokinetic modeling (PBPK)
Now in its second edition, Physiologically Based Pharmacokinetic (PBPK) Modelling and Simulations: Principles, Methods, and Applications in the Pharma Industry remains the premier reference book throughout the rapidly growing PBPK user community. Using clear and concise language, author Sheila Annie Peters connects theory with practice as she explores the vast potential of PBPK modeling for improving drug discovery and development.
This fully updated new edition covers key developments in the field of PBPK modelling and simulations that have emerged in recent years. A brand-new section provides case studies in different application areas of PBPK modelling, including drug-drug interaction, genetic polymorphism, renal impairment, and pediatric extrapolation. Additional chapters address topics such as model-informed drug development (MIDD) and expose readers to a wide range of current applications in the field. Throughout the book, substantially revised chapters simplify complex topics and offer a balanced view of both the opportunities and challenges of PBPK modelling. Providing timely and comprehensive coverage of one of the most exciting new areas of pharmaceutical science, this book:
Describes the principles behind physiological modeling of pharmacokinetic processes, inter-individual variability, and drug interactions for small molecule drugs and biologics
Features a wealth of new figures and case studies of the applications of PBPK modelling along the value chain in drug discovery and development
Reflects the latest regulatory guidelines on the reporting of PBPK modelling analysis
Includes access to a new companion website containing code, datasets, explanations of case examples in the text, and discussion of key developments in the field
Contains a brief overview of the field, end-of-chapter keywords for easy reference, and an extensive bibliography
Physiologically-Based Pharmacokinetic (PBPK) Modeling and Simulations: Principles, Methods, and Applications in the Pharmaceutical Industry, Second Edition is an indispensable single-volume resource for beginning and intermediate practitioners across the pharmaceutical sciences in both industry and academia.
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