Multivariate Analysis in the Pharmaceutical Industry Book

Multivariate Analysis in the Pharmaceutical Industry


  • Author : Ana Patricia Ferreira
  • Publisher : Academic Press
  • Release Date : 2018-04-24
  • Genre: Medical
  • Pages : 464
  • ISBN 10 : 9780128110669

GET BOOK
Multivariate Analysis in the Pharmaceutical Industry Excerpt :

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 Book

Chemical Engineering in the Pharmaceutical Industry


  • Author : Mary T. am Ende
  • Publisher : John Wiley & Sons
  • Release Date : 2019-04-09
  • Genre: Technology & Engineering
  • Pages : 688
  • ISBN 10 : 9781119285496

GET BOOK
Chemical Engineering in the Pharmaceutical Industry Excerpt :

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 sc

Chemical Engineering in the Pharmaceutical Industry Book

Chemical Engineering in the Pharmaceutical Industry


  • Author : Mary T. am Ende
  • Publisher : John Wiley & Sons
  • Release Date : 2019-04-08
  • Genre: Technology & Engineering
  • Pages : 688
  • ISBN 10 : 9781119285502

GET BOOK
Chemical Engineering in the Pharmaceutical Industry Excerpt :

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 sc

Using Multivariate Analysis for Pharmaceutical Drug Product Development Book

Using Multivariate Analysis for Pharmaceutical Drug Product Development


  • Author : Yifan Wang
  • Publisher : Unknown
  • Release Date : 2016
  • Genre: Drug development
  • Pages : 208
  • ISBN 10 : OCLC:975363211

GET BOOK
Using Multivariate Analysis for Pharmaceutical Drug Product Development Excerpt :

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.

Chemical Engineering in the Pharmaceutical Industry Book

Chemical Engineering in the Pharmaceutical Industry


  • Author : David J. am Ende
  • Publisher : John Wiley & Sons
  • Release Date : 2011-03-10
  • Genre: Technology & Engineering
  • Pages : 904
  • ISBN 10 : 9781118088104

GET BOOK
Chemical Engineering in the Pharmaceutical Industry Excerpt :

This book deals with various unique elements in the drugdevelopment process within chemical engineering science andpharmaceutical R&D. The book is intended to be used as aprofessional reference and potentially as a text book reference inpharmaceutical engineering and pharmaceutical sciences. Many of theexperimental methods related to pharmaceutical process developmentare learned on the job. This book is intended to provide many ofthose important concepts that R&D Engineers and manufacturingEngineers should know and be familiar if they are going to besuccessful in the Pharmaceutical Industry. These include basicanalytics for quantitation of reaction components– oftenskipped in ChE Reaction Engineering and kinetics books. In additionChemical Engineering in the Pharmaceutical Industryintroduces contemporary methods of data analysis for kineticmodeling and extends these concepts into Quality by Designstrategies for regulatory filings. For the current professionals,in-silico process modeling tools that streamlineexperimental screening approaches is also new and presented here.Continuous flow processing, although mainstream for ChE, is uniquein this context given the range of scales and the complex economicsassociated 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 techniquesfor engineers, thermodynamic modeling, and finally provides anappendix with common engineering tools and examples of theirapplications.

Statistics In the Pharmaceutical Industry Book

Statistics In the Pharmaceutical Industry


  • Author : C. Ralph Buncher
  • Publisher : CRC Press
  • Release Date : 2019-03-07
  • Genre: Mathematics
  • Pages : 504
  • ISBN 10 : 9781420056457

GET BOOK
Statistics In the Pharmaceutical Industry Excerpt :

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.

Equipment Qualification in the Pharmaceutical Industry Book

Equipment Qualification in the Pharmaceutical Industry


  • Author : Steven Ostrove
  • Publisher : Academic Press
  • Release Date : 2019-06-13
  • Genre: Business & Economics
  • Pages : 234
  • ISBN 10 : 9780128175699

GET BOOK
Equipment Qualification in the Pharmaceutical Industry Excerpt :

Equipment Qualification in the Pharmaceutical Industry provides guidance and basic information for the preparation of a quality qualification program. It has been noted that there is a general lack of understanding in the industry, especially for those new to the industry, as to what constitutes a compliant qualification program. Even experienced professionals have felt a lack of security in reaching a compliant state. This book outlines a guideline for the preparation and execution of qualification protocols including the installation (IQ), operational (OQ), and performance (PQ) protocols. It discusses the importance of related qualification programs (e.g., quality systems, commissioning, computer system, and cleaning) and how to incorporate them into a fully compliant qualification program. Furthermore, it provides matrices of what could be included in each type of protocol for major types of process equipment. While primarily for people entering the pharmaceutical industry, those established in the field will benefit from the multiple examples and matrices as well as integration of related systems. Equipment Qualification in the Pharmaceutical Industry provides students and pharmaceutical scientists a guideline for the preparation and execution of qualification (installation, operational, and performance) protocols. Incorporates good manufacturing processes into a compliant qualification program Provides examples of protocol layout Includes matrices for major process equipment, installation quality, operational quality, and performance quality requirements

Exploratory Multivariate Analysis by Example Using R Book

Exploratory Multivariate Analysis by Example Using R


  • Author : Francois Husson
  • Publisher : CRC Press
  • Release Date : 2017-04-25
  • Genre: Mathematics
  • Pages : 262
  • ISBN 10 : 9781315301860

GET BOOK
Exploratory Multivariate Analysis by Example Using R Excerpt :

Full of real-world case studies and practical advice, Exploratory Multivariate Analysis by Example Using R, Second Edition focuses on four fundamental methods of multivariate exploratory data analysis that are most suitable for applications. It covers principal component analysis (PCA) when variables are quantitative, correspondence analysis (CA) a

Exploratory Multivariate Analysis by Example Using R Book

Exploratory Multivariate Analysis by Example Using R


  • Author : Francois Husson
  • Publisher : CRC Press
  • Release Date : 2010-11-15
  • Genre: Mathematics
  • Pages : 240
  • ISBN 10 : 9781439835814

GET BOOK
Exploratory Multivariate Analysis by Example Using R Excerpt :

Full of real-world case studies and practical advice, Exploratory Multivariate Analysis by Example Using R focuses on four fundamental methods of multivariate exploratory data analysis that are most suitable for applications. It covers principal component analysis (PCA) when variables are quantitative, correspondence analysis (CA) and multiple correspondence analysis (MCA) when variables are categorical, and hierarchical cluster analysis. The authors take a geometric point of view that provides a unified vision for exploring multivariate data tables. Within this framework, they present the principles, indicators, and ways of representing and visualizing objects that are common to the exploratory methods. The authors show how to use categorical variables in a PCA context in which variables are quantitative, how to handle more than two categorical variables in a CA context in which there are originally two variables, and how to add quantitative variables in an MCA context in which variables are categorical. They also illustrate the methods and the ways they can be exploited using examples from various fields. Throughout the text, each result correlates with an R command accessible in the FactoMineR package developed by the authors. All of the data sets and code are available at http://factominer.free.fr/book By using the theory, examples, and software presented in this book, readers will be fully equipped to tackle real-life multivariate data.

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture Book

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture


  • Author : Gintaras V. Reklaitis
  • Publisher : John Wiley & Sons
  • Release Date : 2017-10-09
  • Genre: Science
  • Pages : 416
  • ISBN 10 : 9780470942376

GET BOOK
Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture Excerpt :

This book is a structured approach to designing a product and its associated manufacturing process. It shows pharmaceutical engineers and scientists involved in product and process development how to utilize QbD practices and applications effectively while complying with government regulations. Material includes discussion of how to utilize design space, models, process control methodology, and cumulative process knowledge to seek improvements in manufacturing, while maintaining and enhancing product performance. Edited by three renowned researchers in the field, this invaluable resource is an essential tool for all pharmaceutical professionals.

Developing Solid Oral Dosage Forms Book
Score: 5
From 1 Ratings

Developing Solid Oral Dosage Forms


  • Author : Yihong Qiu
  • Publisher : Academic Press
  • Release Date : 2016-11-08
  • Genre: Medical
  • Pages : 1176
  • ISBN 10 : 9780128026373

GET BOOK
Developing Solid Oral Dosage Forms Excerpt :

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

Chemical Engineering in the Pharmaceutical Industry  Active Pharmaceutical Ingredients Book

Chemical Engineering in the Pharmaceutical Industry Active Pharmaceutical Ingredients


  • Author : David J. am Ende
  • Publisher : Wiley
  • Release Date : 2019-04-23
  • Genre: Technology & Engineering
  • Pages : 1168
  • ISBN 10 : 9781119285861

GET BOOK
Chemical Engineering in the Pharmaceutical Industry Active Pharmaceutical Ingredients Excerpt :

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

PAT Applied in Biopharmaceutical Process Development And Manufacturing Book

PAT Applied in Biopharmaceutical Process Development And Manufacturing


  • Author : Cenk Undey
  • Publisher : CRC Press
  • Release Date : 2011-12-07
  • Genre: Medical
  • Pages : 327
  • ISBN 10 : 9781439829455

GET BOOK
PAT Applied in Biopharmaceutical Process Development And Manufacturing Excerpt :

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.

Analysis of Multivariate Social Science Data Book

Analysis of Multivariate Social Science Data


  • Author : David J. Bartholomew
  • Publisher : CRC Press
  • Release Date : 2008-06-04
  • Genre: Mathematics
  • Pages : 384
  • ISBN 10 : 9781584889618

GET BOOK
Analysis of Multivariate Social Science Data Excerpt :

Drawing on the authors' varied experiences working and teaching in the field, Analysis of Multivariate Social Science Data, Second Editionenables a basic understanding of how to use key multivariate methods in the social sciences. With updates in every chapter, this edition expands its topics to include regression analysis, con