Continuous Manufacturing of Pharmaceuticals

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Publisher : John Wiley & Sons
ISBN 13 : 1119001323
Total Pages : 645 pages
Book Rating : 4.1/5 (19 download)

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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 2017-09-05 with total page 645 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.

Continuous Manufacturing for the Modernization of Pharmaceutical Production

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Author :
Publisher : National Academies Press
ISBN 13 : 0309487811
Total Pages : 69 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Continuous Manufacturing for the Modernization of Pharmaceutical Production by : National Academies of Sciences, Engineering, and Medicine

Download or read book Continuous Manufacturing for the Modernization of Pharmaceutical Production written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-04-05 with total page 69 pages. Available in PDF, EPUB and Kindle. Book excerpt: On July 30-31, 2018, the National Academies of Sciences, Engineering, and Medicine held a workshop titled Continuous Manufacturing for the Modernization of Pharmaceutical Production. This workshop discussed the business and regulatory concerns associated with adopting continuous manufacturing techniques to produce biologics such as enzymes, monoclonal antibodies, and vaccines. The participants also discussed specific challenges for integration across the manufacturing system, including upstream and downstream processes, analytical techniques, and drug product development. The workshop addressed these challenges broadly across the biologics domain but focused particularly on drug categories of greatest FDA and industrial interest such as monoclonal antibodies and vaccines. This publication summarizes the presentations and discussions from the workshop.

12th International Symposium on Process Systems Engineering and 25th European Symposium on Computer Aided Process Engineering

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Publisher : Elsevier
ISBN 13 : 0444634452
Total Pages : 2667 pages
Book Rating : 4.4/5 (446 download)

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Book Synopsis 12th International Symposium on Process Systems Engineering and 25th European Symposium on Computer Aided Process Engineering by :

Download or read book 12th International Symposium on Process Systems Engineering and 25th European Symposium on Computer Aided Process Engineering written by and published by Elsevier. This book was released on 2015-07-14 with total page 2667 pages. Available in PDF, EPUB and Kindle. Book excerpt: 25th European Symposium on Computer-Aided Process Engineering contains the papers presented at the 12th Process Systems Engineering (PSE) and 25th European Society of Computer Aided Process Engineering (ESCAPE) Joint Event held in Copenhagen, Denmark, 31 May - 4 June 2015. The purpose of these series is to bring together the international community of researchers and engineers who are interested in computing-based methods in process engineering. This conference highlights the contributions of the PSE/CAPE community towards the sustainability of modern society. Contributors from academia and industry establish the core products of PSE/CAPE, define the new and changing scope of our results, and future challenges. Plenary and keynote lectures discuss real-world challenges (globalization, energy, environment, and health) and contribute to discussions on the widening scope of PSE/CAPE versus the consolidation of the core topics of PSE/CAPE. - Highlights how the Process Systems Engineering/Computer-Aided Process Engineering community contributes to the sustainability of modern society - Presents findings and discussions from both the 12th Process Systems Engineering (PSE) and 25th European Society of Computer-Aided Process Engineering (ESCAPE) Events - Establishes the core products of Process Systems Engineering/Computer Aided Process Engineering - Defines the future challenges of the Process Systems Engineering/Computer Aided Process Engineering community

Continuous Pharmaceutical Processing and Process Analytical Technology

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Publisher : CRC Press
ISBN 13 : 1000804496
Total Pages : 723 pages
Book Rating : 4.0/5 (8 download)

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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 723 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

21st European Symposium on Computer Aided Process Engineering

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Author :
Publisher : Elsevier
ISBN 13 : 044453895X
Total Pages : 2087 pages
Book Rating : 4.4/5 (445 download)

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Book Synopsis 21st European Symposium on Computer Aided Process Engineering by : E. N. Pistikopoulos

Download or read book 21st European Symposium on Computer Aided Process Engineering written by E. N. Pistikopoulos and published by Elsevier. This book was released on 2011-07-21 with total page 2087 pages. Available in PDF, EPUB and Kindle. Book excerpt: The European Symposium on Computer Aided Process Engineering (ESCAPE) series presents the latest innovations and achievements of leading professionals from the industrial and academic communities. The ESCAPE series serves as a forum for engineers, scientists, researchers, managers and students to present and discuss progress being made in the area of computer aided process engineering (CAPE). European industries large and small are bringing innovations into our lives, whether in the form of new technologies to address environmental problems, new products to make our homes more comfortable and energy efficient or new therapies to improve the health and well being of European citizens. Moreover, the European Industry needs to undertake research and technological initiatives in response to humanity's "Grand Challenges," described in the declaration of Lund, namely, Global Warming, Tightening Supplies of Energy, Water and Food, Ageing Societies, Public Health, Pandemics and Security. Thus, the Technical Theme of ESCAPE 21 will be "Process Systems Approaches for Addressing Grand Challenges in Energy, Environment, Health, Bioprocessing & Nanotechnologies."

Predictive Modeling of Pharmaceutical Unit Operations

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Publisher : Woodhead Publishing
ISBN 13 : 0081001800
Total Pages : 465 pages
Book Rating : 4.0/5 (81 download)

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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 465 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

Process Systems Engineering for Pharmaceutical Manufacturing

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Author :
Publisher : Elsevier
ISBN 13 : 0444639667
Total Pages : 700 pages
Book Rating : 4.4/5 (446 download)

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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 700 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

Optimization of Pharmaceutical Processes

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Author :
Publisher : Springer Nature
ISBN 13 : 3030909247
Total Pages : 437 pages
Book Rating : 4.0/5 (39 download)

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Book Synopsis Optimization of Pharmaceutical Processes by : Antonios Fytopoulos

Download or read book Optimization of Pharmaceutical Processes written by Antonios Fytopoulos and published by Springer Nature. This book was released on 2022-04-06 with total page 437 pages. Available in PDF, EPUB and Kindle. Book excerpt: Optimization of Pharmaceutical Processes presents contributions from leading authorities in the fields of optimization and pharmaceutical manufacturing. Formulated within structured frameworks, practical examples and applications are given as guidance to apply optimization techniques to most aspects of pharmaceutical processes from design, to lab and pilot scale, and finally to manufacturing. The increasing demand for better quality, higher yield, more efficient-optimized and green pharmaceutical processes, indicates that optimal conditions for production must be applied to achieve simplicity, lower costs and superior yield. The application of such methods in the pharmaceutical industry is not trivial. Quality of the final product is of major importance to human health and the need for deep knowledge of the process parameters and the optimization of the processes are imperative. The volume, which includes new methods as well as review contributions will benefit a wide readership including engineers in pharmaceuticals, chemical, biological, to name just a few.

Integration and Optimization of Unit Operations

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Author :
Publisher : Elsevier
ISBN 13 : 0128236183
Total Pages : 464 pages
Book Rating : 4.1/5 (282 download)

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Book Synopsis Integration and Optimization of Unit Operations by : Barry A. Perlmutter

Download or read book Integration and Optimization of Unit Operations written by Barry A. Perlmutter and published by Elsevier. This book was released on 2022-06-24 with total page 464 pages. Available in PDF, EPUB and Kindle. Book excerpt: The chemical industry changes and becomes more and more integrated worldwide. This creates a need for information exchange that includes not only the principles of operation but also the transfer of practical knowledge. Integration and Optimization of Unit Operations provides up-to-date and practical information on chemical unit operations from the R&D stage to scale-up and demonstration to commercialization and optimization. A global collection of industry experts systematically discuss all innovation stages, complex processes with different unit operations, including solids processing and recycle flows, and the importance of integrated process validation. The book addresses the needs of engineers who want to increase their skill levels in various disciplines so that they are able to develop, commercialize and optimize processes. After reading this book, you will be able to acquire new skills and knowledge to collaborate across disciplines and develop creative solutions. - Shows the impacts of upstream process decisions on downstream operations - Provides troubleshooting strategies at each process stage - Asks challenging questions to develop creative solutions to process problems

Proceedings of the 8th International Conference on Foundations of Computer-Aided Process Design

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Author :
Publisher : Elsevier
ISBN 13 : 0444634428
Total Pages : 835 pages
Book Rating : 4.4/5 (446 download)

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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 835 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

Model-Based Tools for Pharmaceutical Manufacturing Processes

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Publisher : MDPI
ISBN 13 : 303928424X
Total Pages : 188 pages
Book Rating : 4.0/5 (392 download)

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Book Synopsis Model-Based Tools for Pharmaceutical Manufacturing Processes by : Krist V. Gernaey

Download or read book Model-Based Tools for Pharmaceutical Manufacturing Processes written by Krist V. Gernaey and published by MDPI. This book was released on 2020-03-13 with total page 188 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Special Issue on “Model-Based Tools for Pharmaceutical Manufacturing Processes” will curate novel advances in the development and application of model-based tools to address ever-present challenges of the traditional pharmaceutical manufacturing practice as well as new trends. This book provides a collection of nine papers on original advances in the model-based process unit, system-level, quality-by-design under uncertainty, and decision-making applications of pharmaceutical manufacturing processes.

31st European Symposium on Computer Aided Process Engineering

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Publisher : Elsevier
ISBN 13 : 0323885136
Total Pages : 2146 pages
Book Rating : 4.3/5 (238 download)

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Book Synopsis 31st European Symposium on Computer Aided Process Engineering by : Metin Türkay

Download or read book 31st European Symposium on Computer Aided Process Engineering written by Metin Türkay and published by Elsevier. This book was released on 2021-07-22 with total page 2146 pages. Available in PDF, EPUB and Kindle. Book excerpt: The 31st European Symposium on Computer Aided Process Engineering: ESCAPE-31, Volume 50 contains the papers presented at the 31st European Symposium of Computer Aided Process Engineering (ESCAPE) event held in Istanbul, Turkey. It is a valuable resource for chemical engineers, chemical process engineers, researchers in industry and academia, students and consultants in the chemical industries. - Presents findings and discussions from the 31st European Symposium of Computer Aided Process Engineering (ESCAPE) event

Chemical Engineering in the Pharmaceutical Industry

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Publisher : John Wiley & Sons
ISBN 13 : 1119285887
Total Pages : 1166 pages
Book Rating : 4.1/5 (192 download)

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Book Synopsis Chemical Engineering in the Pharmaceutical Industry by : David J. am Ende

Download or read book Chemical Engineering in the Pharmaceutical Industry written by David J. am Ende and published by John Wiley & Sons. This book was released on 2019-03-28 with total page 1166 pages. Available in PDF, EPUB and Kindle. Book excerpt: A guide to the development and manufacturing of pharmaceutical products written for professionals in the industry, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry is a practical book that highlights chemistry and chemical engineering. The book’s regulatory quality strategies target the development and manufacturing of pharmaceutically active ingredients of pharmaceutical products. The expanded second edition contains revised content with many new case studies and additional example calculations that are of interest to chemical engineers. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling. The active pharmaceutical ingredients book puts the focus on the chemistry, chemical engineering, and unit operations specific to development and manufacturing of the active ingredients of the pharmaceutical product. The drug substance operations section includes information on chemical reactions, mixing, distillations, extractions, crystallizations, filtration, drying, and wet and dry milling. In addition, the book includes many applications of process modeling and modern software tools that are geared toward batch-scale and continuous drug substance pharmaceutical operations. This updated second edition: Contains 30new chapters or revised chapters specific to API, covering topics including: manufacturing quality by design, computational approaches, continuous manufacturing, crystallization and final form, process safety Expanded topics of scale-up, continuous processing, applications of thermodynamics and thermodynamic modeling, filtration and drying Presents updated and expanded example calculations Includes contributions from noted experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduate students, and professionals in the field of pharmaceutical sciences and manufacturing, the second edition of Chemical Engineering in the Pharmaceutical Industryf ocuses on the development and chemical engineering as well as operations specific to the design, formulation, and manufacture of drug substance and products.

Continuous Processing in Pharmaceutical Manufacturing

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Publisher : John Wiley & Sons
ISBN 13 : 3527335951
Total Pages : 528 pages
Book Rating : 4.5/5 (273 download)

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Book Synopsis Continuous Processing in Pharmaceutical Manufacturing by : Ganapathy Subramanian

Download or read book Continuous Processing in Pharmaceutical Manufacturing written by Ganapathy Subramanian and published by John Wiley & Sons. This book was released on 2015-02-09 with total page 528 pages. Available in PDF, EPUB and Kindle. Book excerpt: With contributions from biotechnologists and bioengineers, this ready reference describes the state of the art in industrial biopharmaceutical production, with a strong focus on continuous processes. Recent advances in single-use technology as well as application guidelines for all types of biopharmaceutical products, from vaccines to antibodies, and from bacterial to insect to mammalian cells are covered. The efficiency, robustness, and quality control of continuous production processes for biopharmaceuticals are reviewed and compared to traditional batch processes for a range of different production systems.

Industry 4.0 Vision for the Supply of Energy and Materials

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Publisher : John Wiley & Sons
ISBN 13 : 1119695937
Total Pages : 404 pages
Book Rating : 4.1/5 (196 download)

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Book Synopsis Industry 4.0 Vision for the Supply of Energy and Materials by : Mahdi Sharifzadeh

Download or read book Industry 4.0 Vision for the Supply of Energy and Materials written by Mahdi Sharifzadeh and published by John Wiley & Sons. This book was released on 2022-06-01 with total page 404 pages. Available in PDF, EPUB and Kindle. Book excerpt: Industry 4.0 Vision for the Supply of Energy and Materials Explore the impact of Industry 4.0 technologies on the supply chain with this authoritative text written by a leader in his field In Industry 4.0 Vision for the Supply of Energy and Materials, distinguished researcher and editor, Dr. Mahdi Sharifzadeh, delivers thematic, analytic, and applied discussions of the Industry 4.0 vision for supply chain design and operation. The book compiles all current aspects and emerging notions of Industry 4.0 into clusters of "enablers" and "analytics" of Supply Chain 4.0. Their multifaceted and highly interconnected nature is discussed at length, as are their diverse range of applications. You will discover uses of these new technologies ranging from the supply of conventional energy networks to renewables, pharmaceuticals, and additive manufacturing. You will also learn about their implications for economic prosperity and environmental sustainability. For each sector, this book scrutinizes current industrial practice and discusses developing concepts. Finally, the book concludes with potential future research directions of interest to industry practitioners and academics alike. Readers will also benefit from the inclusion of: A thorough introduction to connectivity through wireless communications and remote sensors An exploration of blockchains and smart contracts, as well as robotics and automation and cloud computing Practical discussions of supply chain analytics, including big data, machine-learning, and artificial intelligence, as well as supply chain modeling, optimization, and control A concise treatment of Industry 4.0 applications in supply chain design and operation, including the circular economy and the power industry An analysis of the oil, gas, and petrochemical industry, the pharmaceutical industry, and additive manufacturing Perfect for PhD-level and Postdoctoral researchers and industrial researchers, Industry 4.0 Vision for the Supply of Energy and Materials will also earn a place in the libraries of working professionals with an interest in the quantitative analysis of Supply Chain 4.0 concepts and techniques.

Computer-Aided Applications in Pharmaceutical Technology

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Author :
Publisher : Elsevier
ISBN 13 : 0443186561
Total Pages : 340 pages
Book Rating : 4.4/5 (431 download)

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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 2023-09-07 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

Feature Papers

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Author :
Publisher : MDPI
ISBN 13 : 3038420700
Total Pages : 405 pages
Book Rating : 4.0/5 (384 download)

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Book Synopsis Feature Papers by : Michael Henson

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