Multivariate Analysis In The Pharmaceutical Industry

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Multivariate Analysis in the Pharmaceutical Industry

Multivariate Analysis in the Pharmaceutical Industry
  • Author : Ana Patricia Ferreira,Jose C. Menezes,Mike Tobyn
  • Publisher : Academic Press
  • Release Date : 2018-04-24
  • Total pages : 464
  • ISBN : 9780128110669
  • File Size : 18,6 Mb
  • Total Download : 739
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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

Multivariate Analysis in the Pharmaceutical Industry

Multivariate Analysis in the Pharmaceutical Industry
  • Author : Ana Patricia Ferreira,Jose C. Menezes,Mike Tobyn
  • Publisher : Academic Press
  • Release Date : 2018-04-27
  • Total pages : 464
  • ISBN : 0128110651
  • File Size : 25,6 Mb
  • Total Download : 500
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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

Chemical Engineering in the Pharmaceutical Industry

Chemical Engineering in the Pharmaceutical Industry
  • Author : Mary T. am Ende,David J. am Ende
  • Publisher : John Wiley & Sons
  • Release Date : 2019-04-01
  • Total pages : 688
  • ISBN : 9781119285519
  • File Size : 39,9 Mb
  • Total Download : 509
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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.

Patent protection and economic development

Patent protection and economic development
  • Author : Axel Sell,Monika Mundkowski-Bek
  • Publisher : Unknown
  • Release Date : 1977
  • Total pages : 50
  • ISBN : OCLC:74435866
  • File Size : 39,9 Mb
  • Total Download : 594
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PDF book entitled Patent protection and economic development written by Axel Sell,Monika Mundkowski-Bek and published by Unknown which was released on 1977 with total hardcover pages 50, the book become popular and critical acclaim.

Approaching Multivariate Analysis, 2nd Edition

Approaching Multivariate Analysis, 2nd Edition
  • Author : Pat Dugard,John Todman,Harry Staines
  • Publisher : Taylor & Francis
  • Release Date : 2022-06-30
  • Total pages : 440
  • ISBN : 9781000787252
  • File Size : 52,8 Mb
  • Total Download : 195
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This fully updated new edition not only provides an introduction to a range of advanced statistical techniques that are used in psychology, but has been expanded to include new chapters describing methods and examples of particular interest to medical researchers. It takes a very practical approach, aimed at enabling readers to begin using the methods to tackle their own problems. This book provides a non-mathematical introduction to multivariate methods, with an emphasis on helping the reader gain an intuitive understanding of what each method is for, what it does and how it does it. The first chapter briefly reviews the main concepts of univariate and bivariate methods and provides an overview of the multivariate methods that will be discussed, bringing out the relationships among them, and summarising how to recognise what types of problem each of them may be appropriate for tackling. In the remaining chapters, introductions to the methods and important conceptual points are followed by the presentation of typical applications from psychology and medicine, using examples with fabricated data. Instructions on how to do the analyses and how to make sense of the results are fully illustrated with dialogue boxes and output tables from SPSS, as well as details of how to interpret and report the output, and extracts of SPSS syntax and code from relevant SAS procedures. This book gets students started, and prepares them to approach more comprehensive treatments with confidence. This makes it an ideal text for psychology students, medical students and students or academics in any discipline that uses multivariate methods.

Chemical Engineering in the Pharmaceutical Industry

Chemical Engineering in the Pharmaceutical Industry
  • Author : David J. am Ende
  • Publisher : John Wiley & Sons
  • Release Date : 2011-03-10
  • Total pages : 1547
  • ISBN : 9781118088104
  • File Size : 9,5 Mb
  • Total Download : 799
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This book deals with various unique elements in the drug development process within chemical engineering science and pharmaceutical R&D. The book is intended to be used as a professional reference and potentially as a text book reference in pharmaceutical engineering and pharmaceutical sciences. Many of the experimental methods related to pharmaceutical process development are learned on the job. This book is intended to provide many of those important concepts that R&D Engineers and manufacturing Engineers should know and be familiar if they are going to be successful in the Pharmaceutical Industry. These include basic analytics for quantitation of reaction components– often skipped in ChE Reaction Engineering and kinetics books. In addition Chemical Engineering in the Pharmaceutical Industry introduces contemporary methods of data analysis for kinetic modeling and extends these concepts into Quality by Design strategies for regulatory filings. For the current professionals, in-silico process modeling tools that streamline experimental screening approaches is also new and presented here. Continuous flow processing, although mainstream for ChE, is unique in this context given the range of scales and the complex economics associated with transforming existing batch-plant capacity. The book will be split into four distinct yet related parts. These parts will address the fundamentals of analytical techniques for engineers, thermodynamic modeling, and finally provides an appendix with common engineering tools and examples of their applications.

Statistics In the Pharmaceutical Industry

Statistics In the Pharmaceutical Industry
  • Author : C. Ralph Buncher,Jia-Yeong Tsay
  • Publisher : CRC Press
  • Release Date : 2019-03-07
  • Total pages : 504
  • ISBN : 9781420056457
  • File Size : 24,7 Mb
  • Total Download : 632
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The growth of the pharmaceutical industry over the past decade is astounding, but the impact of this growth on statistics is somewhat confusing. While software has made analysis easier and more efficient, regulatory bodies now demand deeper and more complex analyses, and pharmacogenetic/genomic studies serve up an entirely new set of challenges. For more than two decades, Statistics in the Pharmaceutical Industry has been the definitive guide to sorting through the challenges in the industry, and this Third Edition continues that tradition. Updated and expanded to reflect the most recent trends and developments in the field, Statistics in the Pharmaceutical Industry, Third Edition presents chapters written by experts from both regulatory agencies and pharmaceutical companies who discuss everything from experimental design to post-marketing studies. This approach sheds light on what regulators consider acceptable methodologies and what methods have proven successful for industrial statisticians. Both new and revised chapters reflect the increasingly global nature of the industry as represented by authors from Japan and Europe, the increasing trend toward non-inferiority/equivalence testing, adaptive design in clinical trials, global harmonization of regulatory standards, and multiple comparison studies. The book also examines the latest considerations in anti-cancer studies. Statistics in the Pharmaceutical Industry, Third Edition demystifies the approval process by combining regulatory and industrial points of view, making it a must-read for anyone performing statistical analysis at any point in the drug approval process.

Comprehensive Chemometrics

Comprehensive Chemometrics
  • Author : Steven Brown,Roma Tauler,Beata Walczak
  • Publisher : Elsevier
  • Release Date : 2020-05-26
  • Total pages : 2944
  • ISBN : 9780444641663
  • File Size : 34,9 Mb
  • Total Download : 639
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Comprehensive Chemometrics, Second Edition features expanded and updated coverage, along with new content that covers advances in the field since the previous edition published in 2009. Subject of note include updates in the fields of multidimensional and megavariate data analysis, omics data analysis, big chemical and biochemical data analysis, data fusion and sparse methods. The book follows a similar structure to the previous edition, using the same section titles to frame articles. Many chapters from the previous edition are updated, but there are also many new chapters on the latest developments. Presents integrated reviews of each chemical and biological method, examining their merits and limitations through practical examples and extensive visuals Bridges a gap in knowledge, covering developments in the field since the first edition published in 2009 Meticulously organized, with articles split into 4 sections and 12 sub-sections on key topics to allow students, researchers and professionals to find relevant information quickly and easily Written by academics and practitioners from various fields and regions to ensure that the knowledge within is easily understood and applicable to a large audience Presents integrated reviews of each chemical and biological method, examining their merits and limitations through practical examples and extensive visuals Bridges a gap in knowledge, covering developments in the field since the first edition published in 2009 Meticulously organized, with articles split into 4 sections and 12 sub-sections on key topics to allow students, researchers and professionals to find relevant information quickly and easily Written by academics and practitioners from various fields and regions to ensure that the knowledge within is easily understood and applicable to a large audience

Chemical Engineering in the Pharmaceutical Industry

Chemical Engineering in the Pharmaceutical Industry
  • Author : Mary T. am Ende,David J. am Ende
  • Publisher : John Wiley & Sons
  • Release Date : 2019-04-08
  • Total pages : 688
  • ISBN : 9781119285502
  • File Size : 55,8 Mb
  • Total Download : 623
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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.

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture
  • Author : Gintaras V. Reklaitis,Christine Seymour,Salvador García-Munoz
  • Publisher : John Wiley & Sons
  • Release Date : 2017-10-09
  • Total pages : 418
  • ISBN : 9780470942376
  • File Size : 50,6 Mb
  • Total Download : 302
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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.

Approaching Multivariate Analysis, 2nd Edition

Approaching Multivariate Analysis, 2nd Edition
  • Author : Pat Dugard,John Todman,Harry Staines
  • Publisher : Unknown
  • Release Date : 2013-10-31
  • Total pages : 440
  • ISBN : 0415645913
  • File Size : 15,6 Mb
  • Total Download : 494
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This edition has been expanded to include new chapters describing methods and examples of particular interest to medical researchers It takes a very practical approach, aimed at enabling readers to begin using the methods to tackle their own problems.

Multivariate Analysis for the Biobehavioral and Social Sciences

Multivariate Analysis for the Biobehavioral and Social Sciences
  • Author : Bruce L. Brown,Suzanne B. Hendrix,Dawson W. Hedges,Timothy B. Smith
  • Publisher : John Wiley & Sons
  • Release Date : 2011-11-01
  • Total pages : 496
  • ISBN : 9781118131619
  • File Size : 36,6 Mb
  • Total Download : 299
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An insightful guide to understanding and visualizing multivariatestatistics using SAS®, STATA®, and SPSS® Multivariate Analysis for the Biobehavioral and Social Sciences:A Graphical Approach outlines the essential multivariate methodsfor understanding data in the social and biobehavioral sciences.Using real-world data and the latest software applications, thebook addresses the topic in a comprehensible and hands-on manner,making complex mathematical concepts accessible to readers. The authors promote the importance of clear, well-designedgraphics in the scientific process, with visual representationsaccompanying the presented classical multivariate statisticalmethods . The book begins with a preparatory review of univariatestatistical methods recast in matrix notation, followed by anaccessible introduction to matrix algebra. Subsequent chaptersexplore fundamental multivariate methods and related key concepts,including: Factor analysis and related methods Multivariate graphics Canonical correlation Hotelling's T-squared Multivariate analysis of variance (MANOVA) Multiple regression and the general linear model (GLM) Each topic is introduced with a research-publication case studythat demonstrates its real-world value. Next, the question "how doyou do that?" is addressed with a complete, yet simplified,demonstration of the mathematics and concepts of the method.Finally, the authors show how the analysis of the data is performedusing Stata®, SAS®, and SPSS®. The discussedapproaches are also applicable to a wide variety of modernextensions of multivariate methods as well as modern univariateregression methods. Chapters conclude with conceptual questionsabout the meaning of each method; computational questions that testthe reader's ability to carry out the procedures on simpledatasets; and data analysis questions for the use of the discussedsoftware packages. Multivariate Analysis for the Biobehavioral and Social Sciencesis an excellent book for behavioral, health, and social sciencecourses on multivariate statistics at the graduate level. The bookalso serves as a valuable reference for professionals andresearchers in the social, behavioral, and health sciences whowould like to learn more about multivariate analysis and itsrelevant applications.

Developing Solid Oral Dosage Forms

Developing Solid Oral Dosage Forms
  • Author : Yihong Qiu,Yisheng Chen,Geoff G.Z. Zhang,Lawrence Yu,Rao V. Mantri
  • Publisher : Academic Press
  • Release Date : 2016-11-08
  • Total pages : 1176
  • ISBN : 9780128026373
  • File Size : 16,8 Mb
  • Total Download : 780
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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

PAT Applied in Biopharmaceutical Process Development And Manufacturing

PAT Applied in Biopharmaceutical Process Development And Manufacturing
  • Author : Cenk Undey,Duncan Low,Jose C. Menezes,Mel Koch
  • Publisher : CRC Press
  • Release Date : 2011-12-07
  • Total pages : 330
  • ISBN : 9781439829455
  • File Size : 50,7 Mb
  • Total Download : 284
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As with all of pharmaceutical production, the regulatory environment for the production of therapeutics has been changing as a direct result of the US FDA-initiated Quality by Design (QbD) guidelines and corresponding activities of the International Committee for Harmonization (ICH). Given the rapid growth in the biopharmaceutical area and the complexity of the molecules, the optimum use of which are still being developed, there is a great need for flexible and proactive teams in order to satisfy the regulatory requirements during process development. Process Analytical Technologies (PAT) applied in biopharmaceutical process development and manufacturing have received significant attention in recent years as an enabler to the QbD paradigm. PAT Applied in Biopharmaceutical Process Development and Manufacturing covers technological advances in measurement sciences, data acquisition, monitoring, and control. Technical leaders present real-life case studies in areas including measuring and monitoring raw materials, cell culture, purification, and cleaning and lyophilization processes via advanced PAT. They also explore how data are collected and analyzed using advanced analytical techniques such as multivariate data analysis, monitoring, and control in real-time. Invaluable for experienced practitioners in PAT in biopharmaceuticals, this book is an excellent reference guide for regulatory officials and a vital training aid for students who need to learn the state of the art in this interdisciplinary and exciting area.

Studies in Natural Products Chemistry

Studies in Natural Products Chemistry
  • Author : Atta-ur-Rahman
  • Publisher : Elsevier
  • Release Date : 2022-08-01
  • Total pages : 498
  • ISBN : 9780323911009
  • File Size : 27,8 Mb
  • Total Download : 851
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Natural products in the plant and animal kingdom offer a huge diversity of chemical structures that are the result of biosynthetic processes that have been modulated over the millennia through genetic effects. With the rapid developments in spectroscopic techniques and accompanying advances in high-throughput screening techniques, it has become possible to isolate and then determine the structures and biological activity of natural products rapidly, thus opening up exciting opportunities in the field of new drug development to the pharmaceutical industry. Studies in Natural Products Chemistry covers the synthesis or testing and recording of the medicinal properties of natural products, providing cutting edge accounts of the fascinating developments in the isolation, structure elucidation, synthesis, biosynthesis and pharmacology of a diverse array of bioactive natural products. Focuses on the chemistry of bioactive natural products Contains contributions by leading authorities in the field Presents sources of new pharmacophores

Quality by Design for Biopharmaceutical Drug Product Development

Quality by Design for Biopharmaceutical Drug Product Development
  • Author : Feroz Jameel,Susan Hershenson,Mansoor A. Khan,Sheryl Martin-Moe
  • Publisher : Springer
  • Release Date : 2015-04-01
  • Total pages : 710
  • ISBN : 9781493923168
  • File Size : 23,9 Mb
  • Total Download : 455
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This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key elements of QbD and examine how these elements are integrated into drug product development. These chapters also discuss lessons learned from the FDA Office of Biotechnology Products pilot program. Following chapters demonstrate how QbD is used for formulation development ranging from screening of formulations to developability assessment to development of lyophilized and liquid formats. The next few chapters study the use of small-scale and surrogate models as well as QbD application to drug product processes such as drug substance freezing and thawing, mixing, sterile filtration, filling, lyophilization, inspection and shipping and handling. Later chapters describe more specialized applications of QbD in the drug product realm. This includes the use of QbD in primary containers, devices and combination product development. The volume also explores QbD applied to vaccine development, automation, mathematical modeling and monitoring, and controlling processes and defining control strategies. It concludes with a discussion on the application of QbD to drug product technology transfer as well as overall regulatory considerations and lifecycle management. Quality by Design for Biopharmaceutical Drug Product Development is an authoritative resource for scientists and researchers interested in expanding their knowledge on QbD principles and uses in creating better drugs.

Practical Statistics for Pharmaceutical Analysis

Practical Statistics for Pharmaceutical Analysis
  • Author : James E. De Muth
  • Publisher : Springer Nature
  • Release Date : 2019-12-10
  • Total pages : 245
  • ISBN : 9783030339890
  • File Size : 54,7 Mb
  • Total Download : 541
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This is an introductory statistics book designed to provide scientists with practical information needed to apply the most common statistical tests to laboratory research data. The book is designed to be practical and applicable, so only minimal information is devoted to theory or equations. Emphasis is placed on the underlying principles for effective data analysis and survey the statistical tests. It is of special value for scientists who have access to Minitab software. Examples are provides for all the statistical tests and explanation of the interpretation of these results presented with Minitab (similar to results for any common software package). The book is specifically designed to contribute to the AAPS series on advances in the pharmaceutical sciences. It benefits professional scientists or graduate students who have not had a formal statistics class, who had bad experiences in such classes, or who just fear/don’t understand statistics. Chapter 1 focuses on terminology and essential elements of statistical testing. Statistics is often complicated by synonyms and this chapter established the terms used in the book and how rudiments interact to create statistical tests. Chapter 2 discussed descriptive statistics that are used to organize and summarize sample results. Chapter 3 discussed basic assumptions of probability, characteristics of a normal distribution, alternative approaches for non-normal distributions and introduces the topic of making inferences about a larger population based on a small sample from that population. Chapter 4 discussed hypothesis testing where computer output is interpreted and decisions are made regarding statistical significance. This chapter also deasl with the determination of appropriate sample sizes. The next three chapters focus on tests that make decisions about a population base on a small subset of information. Chapter 5 looks at statistical tests that evaluate where a significant difference exists. In Chapter 6 the tests try to determine the extent and importance of relationships. In contrast to fifth chapter, Chapter 7 presents tests that evaluate the equivalence, not the difference between levels being tested. The last chapter deals with potential outlier or aberrant values and how to statistically determine if they should be removed from the sample data. Each statistical test presented includes an example problem with the resultant software output and how to interpret the results. Minimal time is spent on the mathematical calculations or theory. For those interested in the associated equations, supplemental figures are presented for each test with respective formulas. In addition, Appendix D presents the equations and proof for every output result for the various examples. Examples and results from the appropriate statistical results are displayed using Minitab 18Ò. In addition to the results, the required steps to analyze data using Minitab are presented with the examples for those having access to this software. Numerous other software packages are available, including based data analysis with Excel.

Direct Analysis in Real Time Mass Spectrometry

Direct Analysis in Real Time Mass Spectrometry
  • Author : Yiyang Dong
  • Publisher : John Wiley & Sons
  • Release Date : 2017-11-27
  • Total pages : 360
  • ISBN : 9783527803736
  • File Size : 43,8 Mb
  • Total Download : 426
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Clear, comprehensive, and state of the art, the groundbreaking book on the emerging technology of direct analysis in real time mass spectrometry Written by a noted expert in the field, Direct Analysis in Real Time Mass Spectrometry offers a review of the background and the most recent developments in DART-MS. Invented in 2005, DART-MS offers a wide range of applications for solving numerous analytical problems in various environments, including food science, forensics, and clinical analysis. The text presents an introduction to the history of the technology and includes information on the theoretical background, for exampleon the ionization mechanism. Chapters on sampling and coupling to different types of mass spectrometers are followed by a comprehensive discussion of a broad range of applications. Unlike most other ionization methods, DART does not require laborious sample preparation, as ionization takes place directly on the sample surface. This makes the technique especially attractive for applications in forensics and food science. Comprehensive in scope, this vital text: -Sets the standard on an important and emerging ionization technique -Thoroughly discusses all the relevant aspects from instrumentation to applications -Helps in solving numerous analytical problems in various applications, for example food science, forensics, environmental and clinical analysis -Covers mechanisms, coupling to mass spectrometers, and includes information on challenges and disadvantages of the technique Academics, analytical chemists, pharmaceutical chemists, clinical chemists, forensic scientists, and others will find this illuminating text a must-have resource for understanding the most recent developments in the field.

Profiles of Drug Substances, Excipients, and Related Methodology

Profiles of Drug Substances, Excipients, and Related Methodology
  • Author : Abdulrahman Al-Majed
  • Publisher : Academic Press
  • Release Date : 2022-05-01
  • Total pages : 398
  • ISBN : 9780323854832
  • File Size : 53,5 Mb
  • Total Download : 938
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Profiles of Drug Substances, Excipients, and Related Methodology, Volume 47 covers all aspects of drug development and formulation of drugs, meeting the information needs of the drug development community that are essential to all phases of pharmaceutical development. This updated release includes comprehensive profiles of five drug compounds: Vinpocetine; Loratadine; Ticagrelor; Lodenafil; Danazol. The volume also contains a chapter reviewing “Application of Chemometrics using direct Spectroscopic methods as a QC tool in Pharmaceutical Industry and their Validation. Contains contributions from leading authorities Presents an excellent overview of the physical, chemical and biomedical properties of regularly prescribed drugs Contains a cumulative index for easy access to information

Solid State Development and Processing of Pharmaceutical Molecules

Solid State Development and Processing of Pharmaceutical Molecules
  • Author : Michael Gruss
  • Publisher : John Wiley & Sons
  • Release Date : 2021-11-15
  • Total pages : 578
  • ISBN : 9783527346356
  • File Size : 38,9 Mb
  • Total Download : 783
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Solid State Development and Processing of Pharmaceutical Molecules A guide to the lastest industry principles for optimizing the production of solid state active pharmaceutical ingredients Solid State Development and Processing of Pharmaceutical Molecules is an authoritative guide that covers the entire pharmaceutical value chain. The authors—noted experts on the topic—examine the importance of the solid state form of chemical and biological drugs and review the development, production, quality control, formulation, and stability of medicines. The book explores the most recent trends in the digitization and automation of the pharmaceutical production processes that reflect the need for consistent high quality. It also includes information on relevant regulatory and intellectual property considerations. This resource is aimed at professionals in the pharmaceutical industry and offers an in-depth examination of the commercially relevant issues facing developers, producers and distributors of drug substances. This important book: Provides a guide for the effective development of solid drug forms Compares different characterization methods for solid state APIs Offers a resource for understanding efficient production methods for solid state forms of chemical and biological drugs Includes information on automation, process control, and machine learning as an integral part of the development and production workflows Covers in detail the regulatory and quality control aspects of drug development Written for medicinal chemists, pharmaceutical industry professionals, pharma engineers, solid state chemists, chemical engineers, Solid State Development and Processing of Pharmaceutical Molecules reviews information on the solid state of active pharmaceutical ingredients for their efficient development and production.

Chemical Engineering in the Pharmaceutical Industry

Chemical Engineering in the Pharmaceutical Industry
  • Author : David J. am Ende,Mary T. am Ende
  • Publisher : John Wiley & Sons
  • Release Date : 2019-04-23
  • Total pages : 1168
  • ISBN : 9781119285861
  • File Size : 22,7 Mb
  • Total Download : 397
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Download Chemical Engineering in the Pharmaceutical Industry in PDF, Epub, and Kindle

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.