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Predictive Modeling Of Pharmaceutical Unit Operations
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Book Synopsis Predictive Modeling of Pharmaceutical Unit Operations by : Preetanshu Pandey
Download or read book Predictive Modeling of Pharmaceutical Unit Operations written by Preetanshu Pandey and published by Woodhead Publishing. This book was released on 2016-09-26 with total page 464 pages. Available in PDF, EPUB and Kindle. Book excerpt: The use of modeling and simulation tools is rapidly gaining prominence in the pharmaceutical industry covering a wide range of applications. This book focuses on modeling and simulation tools as they pertain to drug product manufacturing processes, although similar principles and tools may apply to many other areas. Modeling tools can improve fundamental process understanding and provide valuable insights into the manufacturing processes, which can result in significant process improvements and cost savings. With FDA mandating the use of Quality by Design (QbD) principles during manufacturing, reliable modeling techniques can help to alleviate the costs associated with such efforts, and be used to create in silico formulation and process design space. This book is geared toward detailing modeling techniques that are utilized for the various unit operations during drug product manufacturing. By way of examples that include case studies, various modeling principles are explained for the nonexpert end users. A discussion on the role of modeling in quality risk management for manufacturing and application of modeling for continuous manufacturing and biologics is also included. Explains the commonly used modeling and simulation tools Details the modeling of various unit operations commonly utilized in solid dosage drug product manufacturing Practical examples of the application of modeling tools through case studies Discussion of modeling techniques used for a risk-based approach to regulatory filings Explores the usage of modeling in upcoming areas such as continuous manufacturing and biologics manufacturingBullet points
Book Synopsis Chemical Engineering in the Pharmaceutical Industry by : Mary T. am Ende
Download or read book Chemical Engineering in the Pharmaceutical Industry written by Mary T. am Ende and published by John Wiley & Sons. This book was released on 2019-04-01 with total page 688 pages. Available in PDF, EPUB and Kindle. Book excerpt: A guide to the important chemical engineering concepts for the development of new drugs, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry offers a guide to the experimental and computational methods related to drug product design and development. The second edition has been greatly expanded and covers a range of topics related to formulation design and process development of drug products. The authors review basic analytics for quantitation of drug product quality attributes, such as potency, purity, content uniformity, and dissolution, that are addressed with consideration of the applied statistics, process analytical technology, and process control. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling. The contributors explore technology transfer and scale-up of batch processes that are exemplified experimentally and computationally. Written for engineers working in the field, the book examines in-silico process modeling tools that streamline experimental screening approaches. In addition, the authors discuss the emerging field of continuous drug product manufacturing. This revised second edition: Contains 21 new or revised chapters, including chapters on quality by design, computational approaches for drug product modeling, process design with PAT and process control, engineering challenges and solutions Covers chemistry and engineering activities related to dosage form design, and process development, and scale-up Offers analytical methods and applied statistics that highlight drug product quality attributes as design features Presents updated and new example calculations and associated solutions Includes contributions from leading experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduation students, and professionals in the field of pharmaceutical sciences and manufacturing, Chemical Engineering in the Pharmaceutical Industry, Second Edition contains information designed to be of use from the engineer's perspective and spans information from solid to semi-solid to lyophilized drug products.
Book Synopsis Multivariate Analysis in the Pharmaceutical Industry by : Ana Patricia Ferreira
Download or read book Multivariate Analysis in the Pharmaceutical Industry written by Ana Patricia Ferreira and published by Academic Press. This book was released on 2018-04-24 with total page 464 pages. Available in PDF, EPUB and Kindle. Book excerpt: Multivariate Analysis in the Pharmaceutical Industry provides industry practitioners with guidance on multivariate data methods and their applications over the lifecycle of a pharmaceutical product, from process development, to routine manufacturing, focusing on the challenges specific to each step. It includes an overview of regulatory guidance specific to the use of these methods, along with perspectives on the applications of these methods that allow for testing, monitoring and controlling products and processes. The book seeks to put multivariate analysis into a pharmaceutical context for the benefit of pharmaceutical practitioners, potential practitioners, managers and regulators. Users will find a resources that addresses an unmet need on how pharmaceutical industry professionals can extract value from data that is routinely collected on products and processes, especially as these techniques become more widely used, and ultimately, expected by regulators. Targets pharmaceutical industry practitioners and regulatory staff by addressing industry specific challenges Includes case studies from different pharmaceutical companies and across product lifecycle of to introduce readers to the breadth of applications Contains information on the current regulatory framework which will shape how multivariate analysis (MVA) is used in years to come
Book Synopsis Global Supply Chains in the Pharmaceutical Industry by : Nozari, Hamed
Download or read book Global Supply Chains in the Pharmaceutical Industry written by Nozari, Hamed and published by IGI Global. This book was released on 2018-11-09 with total page 373 pages. Available in PDF, EPUB and Kindle. Book excerpt: In a rapidly growing global economy, where there is a constant emergence of new business models and dynamic changes to the business ecosystem, there is a need for the integration of traditional, new, and hybrid concepts in the complex structure of supply chain management. Within the fast-paced pharmaceutical industry, product strategy, life cycles, and distribution must maintain the highest level of agility. Therefore, organizations need strong supply chain capabilities to profitably compete in the marketplace. Global Supply Chains in the Pharmaceutical Industry provides innovative insights into the efforts needed to build and maintain a strong supply chain network in order to achieve efficient fulfillment of demand, drive outstanding customer value, enhance organizational responsiveness, and build network resiliency. This publication is designed for supply chain managers, policymakers, researchers, academicians, and students, and covers topics centered on economic cycles, sustainable development, and new forces in the global economy.
Book Synopsis Pharmaceutical Process Engineering and Scale-up Principles by : Anil B. Jindal
Download or read book Pharmaceutical Process Engineering and Scale-up Principles written by Anil B. Jindal and published by Springer Nature. This book was released on 2023-07-03 with total page 226 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book offers a comprehensive overview of the unit operations involved in the manufacturing process of solid and liquid dosage forms, along with the scale-up of each operation. This book is a valuable resource for professionals working in the pharmaceutical industry and researchers seeking to develop a comprehensive understanding of the various aspects of the manufacturing process. The book is divided into four sections, covering a range of topics. Section I provide readers with a comprehensive understanding of the basic principles behind the manufacturing process of solid and liquid dosage forms. Section II covers the different unit operations involved in the production of solid dosage forms, including mixing, granulation, drying, compression, coating, and size reduction. This section includes case studies to provide readers with practical insights into the scale-up principles involved in the manufacturing process. Section III focuses on the manufacturing and scale-up of liquid formulations, covering topics such as mixing, filtration, and scale-up of liquid mixing process. This section offers a comprehensive understanding of the various aspects of the manufacturing process, including the challenges and opportunities associated with the scale-up of liquid formulations. Finally, Section IV includes two chapters that describe the manufacturing and scale-up of advanced drug delivery systems, including the manufacturing and scale-up of nanoparticles and biotechnology-derived products. This section provides readers with insights into the development of innovative drug delivery systems and the challenges involved in their scale-up. Overall, the book is an essential guide for professionals and researchers seeking a deeper understanding of the manufacturing process. The case studies and practical examples offer valuable insights into the challenges and opportunities involved in the scale-up process, making it an indispensable resource for those involved in the pharmaceutical industry. Only book that is dedicated to pharmaceutical process engineering and scale-up; Contain numerous case studies for easy reference; Covers solid, liquid, and advanced dosage forms.
Book Synopsis Advances in Industrial Machines and Mechanisms by : Y. V. D. Rao
Download or read book Advances in Industrial Machines and Mechanisms written by Y. V. D. Rao and published by Springer Nature. This book was released on 2021-07-20 with total page 719 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book presents the select proceedings of the 1st International 13th National Conference on Industrial Problems on Machines and Mechanism (IPRoMM 2020) and examines issues in the design, manufacture, and performance of mechanical and mechatronic elements and systems that are employed in modern machines and devices. The topics covered include robotics, industrial CAD/CAM systems, mechatronics, machinery associated with conventional and unconventional manufacturing systems, material handling and automated assembly, mechanical and electro-mechanical systems of modern machinery and equipment, micro-devices, compliant mechanisms, hybrid electric vehicle and electric vehicle mechanisms, acoustic and noise control. This book also discusses the recent advances in the integration of IoT and Industry 4.0 in mechanism and machines. The book will be a valuable reference for academicians, researchers, and professionals interested in the design and development of industrial machines.
Download or read book Polyphenols written by Mithun Rudrapal and published by John Wiley & Sons. This book was released on 2023-10-30 with total page 405 pages. Available in PDF, EPUB and Kindle. Book excerpt: Polyphenols Understand polyphenols and their benefits with this comprehensive overview Polyphenols are a group of beneficial compounds—including phenolic acids, flavonoids, anthocyanins, and others—that can be found in a vast range of plants and plant-based foods. Their health benefits and the variety of their applications in functional foods, dietary supplements, and similar areas have made polyphenols a $1 billion market, a figure that is expected to more than double in the next decade. This has placed increased emphasis on areas of cutting-edge research such as the use of bio-based nanodelivery systems to improve the oral bioavailability of polyphenols. Polyphenols constitutes a comprehensive introduction to these compounds, their health benefits, and their potential nutraceutical applications. It incorporates both the biochemical fundamentals of polyphenols and their precise potential to prevent numerous common diseases. The result is an essential reference for a vital, growing area of research and industry. Polyphenols readers will also find: Detailed coverage of polyphenols’ occurrence, bioactivity, and technological applications In-depth discussion of nano-based delivery systems to increase polyphenols’ therapeutic efficacy and oral bioavailability and to reduce required dosages Guidance for developing treatments for cancers, cardiovascular diseases, inflammatory conditions, and more Polyphenols is ideal for food scientists and manufacturers, medicinal chemists, pharmaceutical scientists, and any biochemical or biomedical researcher or professional working with polyphenols or plant-based foods.
Book Synopsis Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture by : Gintaras V. Reklaitis
Download or read book Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture written by Gintaras V. Reklaitis and published by John Wiley & Sons. This book was released on 2017-09-01 with total page 416 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Flexible Automation and Intelligent Manufacturing: Establishing Bridges for More Sustainable Manufacturing Systems by : Francisco J. G. Silva
Download or read book Flexible Automation and Intelligent Manufacturing: Establishing Bridges for More Sustainable Manufacturing Systems written by Francisco J. G. Silva and published by Springer Nature. This book was released on 2023-08-23 with total page 954 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book reports on cutting-edge research and developments in manufacturing, giving a special emphasis to solutions fostering automation and sustainability. Topics cover manufacturing process optimization, remanufacturing, machines and mechanical design, CAD/CAM/CAE, materials characterization and processing, measurement and predictive maintenance techniques. Further topics include artificial intelligence and IoT in manufacturing, robotics, and cutting-edge issues in Industry 4.0/5.0. Based on proceedings of the 32nd edition of the International Conference on Flexible Automation and Intelligent Manufacturing, FAIM 2023, held on June 18 – 22, 2023, in Porto, Portugal, this first volume of a 2-volume set provides academics and professionals with extensive, technical information on trends and technologies in manufacturing, yet it also discusses challenges and practice-oriented experience in all the above-mentioned areas.
Book Synopsis Preparing for FDA Pre-Approval Inspections by : Martin D. Hynes
Download or read book Preparing for FDA Pre-Approval Inspections written by Martin D. Hynes and published by CRC Press. This book was released on 2016-04-19 with total page 310 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Second Edition is an essential guide to preparing for FDA pre-approval inspections-taking into account current trends in FDA expectations and inspection activities, such as the GMPs of the 21st Century, quality systems-based approach to inspections, risk-based inspections, quality by design, process analytical technology, design space, etc. Th
Book Synopsis Continuous Manufacturing of Pharmaceuticals by : Peter Kleinebudde
Download or read book Continuous Manufacturing of Pharmaceuticals written by Peter Kleinebudde and published by John Wiley & Sons. This book was released on 2017-07-14 with total page 632 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive look at existing technologies and processes for continuous manufacturing of pharmaceuticals As rising costs outpace new drug development, the pharmaceutical industry has come under intense pressure to improve the efficiency of its manufacturing processes. Continuous process manufacturing provides a proven solution. Among its many benefits are: minimized waste, energy consumption, and raw material use; the accelerated introduction of new drugs; the use of smaller production facilities with lower building and capital costs; the ability to monitor drug quality on a continuous basis; and enhanced process reliability and flexibility. Continuous Manufacturing of Pharmaceuticals prepares professionals to take advantage of that exciting new approach to improving drug manufacturing efficiency. This book covers key aspects of the continuous manufacturing of pharmaceuticals. The first part provides an overview of key chemical engineering principles and the current regulatory environment. The second covers existing technologies for manufacturing both small-molecule-based products and protein/peptide products. The following section is devoted to process analytical tools for continuously operating manufacturing environments. The final two sections treat the integration of several individual parts of processing into fully operating continuous process systems and summarize state-of-art approaches for innovative new manufacturing principles. Brings together the essential know-how for anyone working in drug manufacturing, as well as chemical, food, and pharmaceutical scientists working on continuous processing Covers chemical engineering principles, regulatory aspects, primary and secondary manufacturing, process analytical technology and quality-by-design Contains contributions from researchers in leading pharmaceutical companies, the FDA, and academic institutions Offers an extremely well-informed look at the most promising future approaches to continuous manufacturing of innovative pharmaceutical products Timely, comprehensive, and authoritative, Continuous Manufacturing of Pharmaceuticals is an important professional resource for researchers in industry and academe working in the fields of pharmaceuticals development and manufacturing.
Book Synopsis Process Systems Engineering for Pharmaceutical Manufacturing by : Ravendra Singh
Download or read book Process Systems Engineering for Pharmaceutical Manufacturing written by Ravendra Singh and published by Elsevier. This book was released on 2018-03-16 with total page 698 pages. Available in PDF, EPUB and Kindle. Book excerpt: Process Systems Engineering for Pharmaceutical Manufacturing: From Product Design to Enterprise-Wide Decisions, Volume 41, covers the following process systems engineering methods and tools for the modernization of the pharmaceutical industry: computer-aided pharmaceutical product design and pharmaceutical production processes design/synthesis; modeling and simulation of the pharmaceutical processing unit operation, integrated flowsheets and applications for design, analysis, risk assessment, sensitivity analysis, optimization, design space identification and control system design; optimal operation, control and monitoring of pharmaceutical production processes; enterprise-wide optimization and supply chain management for pharmaceutical manufacturing processes. Currently, pharmaceutical companies are going through a paradigm shift, from traditional manufacturing mode to modernized mode, built on cutting edge technology and computer-aided methods and tools. Such shifts can benefit tremendously from the application of methods and tools of process systems engineering. Introduces Process System Engineering (PSE) methods and tools for discovering, developing and deploying greener, safer, cost-effective and efficient pharmaceutical production processes Includes a wide spectrum of case studies where different PSE tools and methods are used to improve various pharmaceutical production processes with distinct final products Examines the future benefits and challenges for applying PSE methods and tools to pharmaceutical manufacturing
Book Synopsis Continuous Pharmaceutical Processing and Process Analytical Technology by : Ajit S. Narang
Download or read book Continuous Pharmaceutical Processing and Process Analytical Technology written by Ajit S. Narang and published by CRC Press. This book was released on 2023-03-01 with total page 495 pages. Available in PDF, EPUB and Kindle. Book excerpt: Continuous manufacturing of pharmaceuticals, including aspects of modern process development is highlighted in this book with both the ‘why’ and the ‘how’, emphasizing process modeling and process analytical technologies. Presenting specific case studies and drawing upon extensive experience from industry and academic opinion leaders, this book focuses on the practical aspects of continuous manufacturing. It gives the readers the strategic perspective and technical depth needed to adopt and implement these technologies, where appropriate, in order to gain the competitive edge in speed, agility, and reliability. Features: Discusses scientific solutions and process analytical technology to enable continuous manufacturing in the development of new drugs Includes short stories about how some companies have adopted CM and what their drivers were and what benefits were realized Addresses economic and practical considerations, unlike many other technical books Emphasizes the practical aspects to give the reader the strategic imperative and technological depth to adopt and implement these technologies Highlights the "why" and the "how", focusing on the need analysis and process modeling and process analytical technologies
Book Synopsis Predictive Modeling of Drug Sensitivity by : Ranadip Pal
Download or read book Predictive Modeling of Drug Sensitivity written by Ranadip Pal and published by Academic Press. This book was released on 2016-11-15 with total page 354 pages. Available in PDF, EPUB and Kindle. Book excerpt: Predictive Modeling of Drug Sensitivity gives an overview of drug sensitivity modeling for personalized medicine that includes data characterizations, modeling techniques, applications, and research challenges. It covers the major mathematical techniques used for modeling drug sensitivity, and includes the requisite biological knowledge to guide a user to apply the mathematical tools in different biological scenarios. This book is an ideal reference for computer scientists, engineers, computational biologists, and mathematicians who want to understand and apply multiple approaches and methods to drug sensitivity modeling. The reader will learn a broad range of mathematical and computational techniques applied to the modeling of drug sensitivity, biological concepts, and measurement techniques crucial to drug sensitivity modeling, how to design a combination of drugs under different constraints, and the applications of drug sensitivity prediction methodologies. Applies mathematical and computational approaches to biological problems Covers all aspects of drug sensitivity modeling, starting from initial data generation to final experimental validation Includes the latest results on drug sensitivity modeling that is based on updated research findings Provides information on existing data and software resources for applying the mathematical and computational tools available
Book Synopsis Computer-Aided Applications in Pharmaceutical Technology by : Jelena Duris
Download or read book Computer-Aided Applications in Pharmaceutical Technology written by Jelena Duris and published by Elsevier. This book was released on 2023-09-18 with total page 340 pages. Available in PDF, EPUB and Kindle. Book excerpt: Computer-Aided Applications in Pharmaceutical Technology: Delivery Systems, Dosage Forms, and Pharmaceutical Unit Operations, Second Edition covers the fundamentals of experimental design application and interpretation in pharmaceutical technology, chemometric methods with an emphasis on their applications in process control, neural computing, data science, computer-aided biopharmaceutical characterization, as well as the application of computational fluid dynamics in pharmaceutical technology. Completely updated, the book introduces the theory and practice of computational tools through new case studies. Chapters cover Quality by Design in pharmaceutical development, overview data mining methodologies, present computer-aided formulation development, cover experimental design applications, and much more. Presents a comprehensive review of the current state of the art on various computer-aided applications in pharmaceutical technology Includes case studies to facilitate understanding of various concepts in computer-aided applications Covers applications such as the development of dosage forms and/or delivery systems, pharmaceutical unit operations, and relevant physiologically based pharmacokinetic simulations
Download or read book Feature Papers written by Michael Henson and published by MDPI. This book was released on 2018-10-04 with total page 405 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is a printed edition of the Special Issue "Feature Papers" that was published in Processes
Book Synopsis Proceedings of the 8th International Conference on Foundations of Computer-Aided Process Design by :
Download or read book Proceedings of the 8th International Conference on Foundations of Computer-Aided Process Design written by and published by Elsevier. This book was released on 2014-07-14 with total page 840 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume collects together the presentations at the Eighth International Conference on Foundations of Computer-Aided Process Design, FOCAPD-2014, an event that brings together researchers, educators, and practitioners to identify new challenges and opportunities for process and product design. The chemical industry is currently entering a new phase of rapid evolution. The availability of low-cost feedstocks from natural gas is causing renewed investment in basic chemicals in the OECD, while societal pressures for sustainability and energy security continue to be key drivers in technology development and product selection. This dynamic environment creates opportunities to launch new products and processes and to demonstrate new methodologies for innovation, synthesis and design. FOCAPD-2014 fosters constructive interaction among thought leaders from academia, industry, and government and provides a showcase for the latest research in product and process design. Focuses exclusively on the fundamentals and applications of computer-aided design for the process industries. Provides a fully archival and indexed record of the FOCAPD14 conference Aligns the FOCAPD series with the ESCAPE and PSE series
