Multivariate Analysis in the Pharmaceutical Industry
Multivariate Analysis in the Pharmaceutical Industry

Author: Ana Patricia Ferreira

Publisher: Academic Press

Published: 2018-04-24

Total Pages: 465

ISBN-13: 012811066X

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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

Publisher: John Wiley & Sons

Published: 2019-04-08

Total Pages: 1435

ISBN-13: 111928550X

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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.

Multivariate Analysis for the Biobehavioral and Social Sciences
Multivariate Analysis for the Biobehavioral and Social Sciences

Author: Bruce L. Brown

Publisher: John Wiley & Sons

Published: 2011-11-01

Total Pages: 404

ISBN-13: 1118131614

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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.

Pharmaceutical Quality by Design
Pharmaceutical Quality by Design

Author: Walkiria S. Schlindwein

Publisher: John Wiley & Sons

Published: 2018-01-05

Total Pages: 319

ISBN-13: 1118895215

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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.

Chemical Engineering in the Pharmaceutical Industry
Chemical Engineering in the Pharmaceutical Industry

Author: David J. am Ende

Publisher: John Wiley & Sons

Published: 2011-03-10

Total Pages: 1431

ISBN-13: 1118088107

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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.

Chemical Engineering in the Pharmaceutical Industry
Chemical Engineering in the Pharmaceutical Industry

Author: David J. am Ende

Publisher: John Wiley & Sons

Published: 2019-04-23

Total Pages: 1172

ISBN-13: 1119285860

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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.

Approaching Multivariate Analysis, 2nd Edition
Approaching Multivariate Analysis, 2nd Edition

Author: Pat Dugard

Publisher:

Published: 2013-10-31

Total Pages: 0

ISBN-13: 9780415645911

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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.

Solid State Development and Processing of Pharmaceutical Molecules
Solid State Development and Processing of Pharmaceutical Molecules

Author: Michael Gruss

Publisher: John Wiley & Sons

Published: 2021-11-15

Total Pages: 578

ISBN-13: 352734635X

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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.

Multivariate Data Reduction and Discrimination with SAS Software
Multivariate Data Reduction and Discrimination with SAS Software

Author: Ravindra Khattree

Publisher: Wiley-SAS

Published: 2000-08-14

Total Pages: 0

ISBN-13: 9780471323006

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Easy to read and comprehensive, this book presents descriptive multivariate (DMV) statistical methods using real-world problems and data sets. It offers a unique approach to integrating statistical methods, various kinds of advanced data analyses, and applications of the popular SAS software aids. Emphasis is placed on the correct interpretation of output to draw meaningful conclusions in a variety of disciplines and industries.

An Introduction to Multivariate Data
An Introduction to Multivariate Data

Author: Trevor Cox

Publisher: Wiley

Published: 2009-12-14

Total Pages: 0

ISBN-13: 9780470689189

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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.