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Predictive Modeling Of Pharmaceutical Unit Operations

Author: Preetanshu Pandey
Publisher: Woodhead Publishing
ISBN: 0081001800
Size: 44.93 MB
Format: PDF, Kindle
View: 2705
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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

Global Supply Chains In The Pharmaceutical Industry

Author: Nozari, Hamed
Publisher: IGI Global
ISBN: 1522559221
Size: 24.74 MB
Format: PDF, Docs
View: 4454
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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.

Process Systems Engineering For Pharmaceutical Manufacturing

Author: Ravendra Singh
Publisher: Elsevier
ISBN: 0444639667
Size: 16.24 MB
Format: PDF, ePub, Mobi
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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

Pharmaceutical Unit Operations

Author: Kenneth E. Avis
Publisher: CRC Press
ISBN: 9781574910827
Size: 56.79 MB
Format: PDF, ePub
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This book is a complete, authoritative resource on the coating of tablets, capsules, and other solid dosage forms of therapeutic agents. Fourteen authors cover the industry's technologies. The book begins with a full discussion of the primary processes -- sugar coating, film coating, and microencapsulation -- as well as the rationale for coating, methodologies, formulations, processing methods, and equipment and cleaning. Then it explores automation of the coating process, including hardware and software requirements. Finally, the book examines major stability and quality control issues. Regulations underlie all discussions.

Practical Predictive Analytics And Decisioning Systems For Medicine

Author: Linda Miner
Publisher: Academic Press
ISBN: 012411640X
Size: 38.88 MB
Format: PDF
View: 4123
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With the advent of electronic medical records years ago and the increasing capabilities of computers, our healthcare systems are sitting on growing mountains of data. Not only does the data grow from patient volume but the type of data we store is also growing exponentially. Practical Predictive Analytics and Decisioning Systems for Medicine provides research tools to analyze these large amounts of data and addresses some of the most pressing issues and challenges where data integrity is compromised: patient safety, patient communication, and patient information. Through the use of predictive analytic models and applications, this book is an invaluable resource to predict more accurate outcomes to help improve quality care in the healthcare and medical industries in the most cost–efficient manner. Practical Predictive Analytics and Decisioning Systems for Medicine provides the basics of predictive analytics for those new to the area and focuses on general philosophy and activities in the healthcare and medical system. It explains why predictive models are important, and how they can be applied to the predictive analysis process in order to solve real industry problems. Researchers need this valuable resource to improve data analysis skills and make more accurate and cost-effective decisions. Includes models and applications of predictive analytics why they are important and how they can be used in healthcare and medical research Provides real world step-by-step tutorials to help beginners understand how the predictive analytic processes works and to successfully do the computations Demonstrates methods to help sort through data to make better observations and allow you to make better predictions

Developing Solid Oral Dosage Forms

Author: Yihong Qiu
Publisher: Academic Press
ISBN: 0128026375
Size: 74.50 MB
Format: PDF, Mobi
View: 1176
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Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, Second Edition illustrates how to develop high-quality, safe, and effective pharmaceutical products by discussing the latest techniques, tools, and scientific advances in preformulation investigation, formulation, process design, characterization, scale-up, and production operations. This book covers the essential principles of physical pharmacy, biopharmaceutics, and industrial pharmacy, and their application to the research and development process of oral dosage forms. Chapters have been added, combined, deleted, and completely revised as necessary to produce a comprehensive, well-organized, valuable reference for industry professionals and academics engaged in all aspects of the development process. New and important topics include spray drying, amorphous solid dispersion using hot-melt extrusion, modeling and simulation, bioequivalence of complex modified-released dosage forms, biowaivers, and much more. Written and edited by an international team of leading experts with experience and knowledge across industry, academia, and regulatory settings Includes new chapters covering the pharmaceutical applications of surface phenomenon, predictive biopharmaceutics and pharmacokinetics, the development of formulations for drug discovery support, and much more Presents new case studies throughout, and a section completely devoted to regulatory aspects, including global product regulation and international perspectives

Pharmaceutical Dosage Forms Tablets Third Edition

Author: Larry L. Augsburger
Publisher: CRC Press
ISBN: 1420063863
Size: 71.90 MB
Format: PDF, Mobi
View: 7049
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The ultimate goal of drug product development is to design a system that maximizes the therapeutic potential of the drug substance and facilitates its access to patients. Pharmaceutical Dosage Forms: Tablets, Third Edition is a comprehensive resource of the design, formulation, manufacture, and evaluation of the tablet dosage form, and with over 700 illustrations it guides pharmaceutical scientists and engineers through difficult and technical procedures in a simple easy-to-follow format. New to the third edition:

Refinery Engineering

Author: Ai-Fu Chang
Publisher: John Wiley & Sons
ISBN: 3527666850
Size: 74.18 MB
Format: PDF, Mobi
View: 3068
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A pioneering and comprehensive introduction to the complex subject of integrated refinery process simulation, using many of the tools and techniques currently employed in modern refineries. Adopting a systematic and practical approach, the authors include the theory, case studies and hands-on workshops, explaining how to work with real data. As a result, senior-level undergraduate and graduate students, as well as industrial engineers learn how to develop and use the latest computer models for the predictive modeling and optimization of integrated refinery processes. Additional material is available online providing relevant spreadsheets and simulation files for all the models and examples presented in the book.

Continuous Processing In Pharmaceutical Manufacturing

Author: Ganapathy Subramanian
Publisher: John Wiley & Sons
ISBN: 3527673709
Size: 57.47 MB
Format: PDF
View: 3671
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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.