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Author: Ana Patricia Ferreira
Publisher: Academic Press
ISBN: 012811066X
Category : Medical
Languages : en
Pages : 465
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Book Description
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
Author: Ana Patricia Ferreira
Publisher: Academic Press
ISBN: 012811066X
Category : Medical
Languages : en
Pages : 465
Get Book Here
Book Description
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
Author: Yifan Wang
Publisher:
ISBN:
Category : Drug development
Languages : en
Pages : 208
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Book Description
Manufacturing of pharmaceutical products has a prominent role in the healthcare industry. Generally, the ultimate aim of pharmaceutical development is to release to the market products with acceptable quality. As advanced pharmaceutical manufacturing technologies such as continuous tablet manufacturing, are developed and embraced, it is essential to adopt a scientific, risk-based, and proactive approach for pharmaceutical development. The work presented in this dissertation focuses on using multivariate analysis tools to establish a predictive capability for pharmaceutical process and product development, especially when the amount of materials available is limited. Importantly, the methodologies developed in this dissertation can be applied easily to powder handling and processing in a wider range of industries, such as cosmetic, catalyst, chemical, petrochemical, and food. In this work, methods for analyzing flow properties of raw materials and predict process performance were developed. A method to analyze shear cell data of powders measured under different initial consolidation stresses was introduced. The method was shown to reduce significantly the complexity of shear cell data, and to enabled comparison of materials measured under different initial consolidation stresses. In addition, a predictive correlation between material flow properties and feeder performance was developed. By using multivariate models, the feeding performance of a material with given flow properties can be predicted and quantified. Using a quality-by-design approach, the cohesion of a powder mixture can be predicted based on the concentration of each ingredient. The prediction model was further supplemented by a study investigating two mixing systems. Using statistical analysis, the effect of lubrication on blend flow properties was discussed. By quantifying the correlations between different flow property measurements, mixing systems that have different mixing mechanism were compared. Disadvantages of widely used dissolution comparison methods were addressed. Statistically reliable methodologies to analyze, compare, and predict drug in vitro release profiles were proposed. The proposed methods were shown to be able to consider the self-correlated intrinsic nature of dissolution profiles, and to use within-group variability to estimate the reliability of observations. Additionally, the work presented a case study to improve real-time release testing for advanced tablet manufacturing processes by achieving predictive capability for nondestructive dissolution testing. Using hierarchical multivariate analysis, the validated prediction models were able to predict dissolution profile of an individual tablet based on its NIR spectrum.
Author: Mary T. am Ende
Publisher: John Wiley & Sons
ISBN: 111928550X
Category : Technology & Engineering
Languages : en
Pages : 1435
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Book Description
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.
Author: Bruce L. Brown
Publisher: John Wiley & Sons
ISBN: 1118131614
Category : Mathematics
Languages : en
Pages : 404
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Book Description
An insightful guide to understanding and visualizing multivariate statistics using SAS®, STATA®, and SPSS® Multivariate Analysis for the Biobehavioral and Social Sciences: A Graphical Approach outlines the essential multivariate methods for understanding data in the social and biobehavioral sciences. Using real-world data and the latest software applications, the book 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-designed graphics in the scientific process, with visual representations accompanying the presented classical multivariate statistical methods . The book begins with a preparatory review of univariate statistical methods recast in matrix notation, followed by an accessible introduction to matrix algebra. Subsequent chapters explore 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 study that demonstrates its real-world value. Next, the question "how do you 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 performed using Stata®, SAS®, and SPSS®. The discussed approaches are also applicable to a wide variety of modern extensions of multivariate methods as well as modern univariate regression methods. Chapters conclude with conceptual questions about the meaning of each method; computational questions that test the reader's ability to carry out the procedures on simple datasets; and data analysis questions for the use of the discussed software packages. Multivariate Analysis for the Biobehavioral and Social Sciences is an excellent book for behavioral, health, and social science courses on multivariate statistics at the graduate level. The book also serves as a valuable reference for professionals and researchers in the social, behavioral, and health sciences who would like to learn more about multivariate analysis and its relevant applications.
Author: Axel Sell
Publisher:
ISBN:
Category :
Languages : en
Pages : 50
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Book Description
Author: James E. De Muth
Publisher: Springer Nature
ISBN: 3030339890
Category : Medical
Languages : en
Pages : 257
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Book Description
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.
Author: Trevor Cox
Publisher: Wiley
ISBN: 9780470689189
Category : Mathematics
Languages : en
Pages : 0
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Book Description
A comprehensive overview of multivariate data and analysis Providing an introduction to the subject of multivariate data analysis without delving deeply into underlying theory and concepts, An Introduction to Multivariate Data is an excellent resource for undergraduate statistics courses as well as for professionals who require an understanding of statistical techniques for analyzing their own data sets. Focused on real-world application, the book includes sample exercises in each chapter to firmly cement the concepts covered. Exercises range from simple problems that can be solved by hand or with a calculator, while others require the use of computer-based statistical software.
Author: Walkiria S. Schlindwein
Publisher: John Wiley & Sons
ISBN: 1118895215
Category : Science
Languages : en
Pages : 319
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Book Description
A practical guide to Quality by Design for pharmaceutical product development Pharmaceutical Quality by Design: A Practical Approach outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. Written by experts in the field, the text explores the QbD approach to product development. This innovative approach is based on the application of product and process understanding underpinned by a systematic methodology which can enable pharmaceutical companies to ensure that quality is built into the product. Familiarity with Quality by Design is essential for scientists working in the pharmaceutical industry. The authors take a practical approach and put the focus on the industrial aspects of the new QbD approach to pharmaceutical product development and manufacturing. The text covers quality risk management tools and analysis, applications of QbD to analytical methods, regulatory aspects, quality systems and knowledge management. In addition, the book explores the development and manufacture of drug substance and product, design of experiments, the role of excipients, multivariate analysis, and include several examples of applications of QbD in actual practice. This important resource: Covers the essential information about Quality by Design (QbD) that is at the heart of modern pharmaceutical development Puts the focus on the industrial aspects of the new QbD approach Includes several illustrative examples of applications of QbD in practice Offers advanced specialist topics that can be systematically applied to industry Pharmaceutical Quality by Design offers a guide to the principles and application of Quality by Design (QbD), the holistic approach to manufacturing that offers a complete understanding of the manufacturing processes involved, in order to yield consistent and high quality products.
Author: David J. am Ende
Publisher: John Wiley & Sons
ISBN: 1119285860
Category : Technology & Engineering
Languages : en
Pages : 1172
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Book Description
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.
Author: Pat Dugard
Publisher:
ISBN: 9780415645911
Category : Multivariate analysis
Languages : en
Pages : 0
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Book Description
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.
