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Predictive Modeling Of Pharmaceutical Unit Operations

Author: Preetanshu Pandey
Publisher: Woodhead Publishing
ISBN: 0081001800
Size: 71.52 MB
Format: PDF, ePub
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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

Pharmaceutical Unit Operations

Author: Kenneth E. Avis
Publisher: CRC Press
ISBN: 9781574910827
Size: 45.96 MB
Format: PDF, Mobi
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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.

Multivariate Analysis In The Pharmaceutical Industry

Author: Ana Patricia Ferreira
Publisher: Academic Press
ISBN: 012811066X
Size: 80.32 MB
Format: PDF, Kindle
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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

Developing Solid Oral Dosage Forms

Author: Yihong Qiu
Publisher: Academic Press
ISBN: 0128026375
Size: 68.63 MB
Format: PDF, Mobi
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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

Process Systems Engineering For Pharmaceutical Manufacturing

Author: Ravendra Singh
Publisher: Elsevier
ISBN: 0444639667
Size: 72.56 MB
Format: PDF, Kindle
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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

Practical Predictive Analytics And Decisioning Systems For Medicine

Author: Linda Miner
Publisher: Academic Press
ISBN: 012411640X
Size: 19.54 MB
Format: PDF, Kindle
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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

Handbook Of Modern Pharmaceutical Analysis

Author: Satinder Ahuja
Publisher: Academic Press
ISBN: 9780123759818
Size: 59.50 MB
Format: PDF, ePub, Mobi
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Handbook of Modern Pharmaceutical Analysis, Second Edition, synthesizes the complex research and recent changes in the field, while covering the techniques and technology required for today's laboratories. The work integrates strategy, case studies, methodologies, and implications of new regulatory structures, providing complete coverage of quality assurance from the point of discovery to the point of use. Treats pharmaceutical analysis (PA) as an integral partner to the drug development process rather than as a service to it Covers method development, validation, selection, testing, modeling, and simulation studies combined with advanced exploration of assays, impurity testing, biomolecules, and chiral separations Features detailed coverage of QA, ethics, and regulatory guidance (quality by design, good manufacturing practice), as well as high-tech methodologies and technologies from "lab-on-a-chip" to LC-MS, LC-NMR, and LC-NMR-MS

Pharmaceutical Process Design And Management

Author: Kate McCormick
Publisher: Routledge
ISBN: 1317081404
Size: 41.28 MB
Format: PDF, Mobi
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A quality product or service is the successful and profitable outcome of organising resources, as judged by the final customer. Every business unit needs processes in order to do this effectively; and all processes must be documented so that achievements can be measured and future improvements planned and implemented. Pharmaceutical Process Design and Management takes a step-wise approach to process management. It presents the various elements comprising a process (man, machine, materials, method and environment); it looks at quality control and quality assurance, tools for quality improvements and ways of structuring a process into discrete, fully accountable elements; it proposes that for processes to run successfully, all operators must be the initial problem-solvers; finally, it illustrates how, with the right tools, every problem can be broken down into solvable elements. Learn how to deploy a science and risk-based approach to pharmaceutical manufacturing, by taking a fundamental approach to process design and management and, as a consequence, keep your customers satisfied and your profits healthy.

11th International Symposium On Process Systems Engineering Pse2012

Author:
Publisher: Elsevier
ISBN: 0444595082
Size: 60.55 MB
Format: PDF, ePub
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While the PSE community continues its focus on understanding, synthesizing, modeling, designing, simulating, analyzing, diagnosing, operating, controlling, managing, and optimizing a host of chemical and related industries using the systems approach, the boundaries of PSE research have expanded considerably over the years. While early PSE research was largely concerned with individual units and plants, the current research spans wide ranges of scales in size (molecules to processing units to plants to global multinational enterprises to global supply chain networks; biological cells to ecological webs) and time (instantaneous molecular interactions to months of plant operation to years of strategic planning). The changes and challenges brought about by increasing globalization and the the common global issues of energy, sustainability, and environment provide the motivation for the theme of PSE2012: Process Systems Engineering and Decision Support for the Flat World. Each theme includes an invited chapter based on the plenary presentation by an eminent academic or industrial researcher Reports on the state-of-the-art advances in the various fields of process systems engineering Addresses common global problems and the research being done to solve them