Multivariate Analysis in the Pharmaceutical Industry

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  • Publisher : Academic Press
  • Release : 24 April 2018
  • ISBN : 9780128110669
  • Page : 464 pages
  • Rating : 4.5/5 from 103 voters

Multivariate Analysis in the Pharmaceutical Industry Book PDF summary

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

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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
  • ISBN : 9780128110669
DOWNLOAD BOOKMultivariate Analysis in the Pharmaceutical Industry

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

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
  • ISBN : 9781119285519
DOWNLOAD BOOKChemical Engineering in the Pharmaceutical Industry

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

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
  • ISBN : 9781119285502
DOWNLOAD BOOKChemical Engineering in the Pharmaceutical Industry

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

Patent Protection and Economic Development

Patent Protection and Economic Development
  • Author : Axel Sell,Monica Mundkowski
  • Publisher : Unknown
  • Release Date : 1977
  • ISBN : OCLC:256389462
DOWNLOAD BOOKPatent Protection and Economic Development

Practical Statistics for Pharmaceutical Analysis

Practical Statistics for Pharmaceutical Analysis
  • Author : James E. De Muth
  • Publisher : Springer Nature
  • Release Date : 2019-12-10
  • ISBN : 9783030339890
DOWNLOAD BOOKPractical Statistics for Pharmaceutical Analysis

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

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
  • ISBN : 9781118088104
DOWNLOAD BOOKChemical Engineering in the Pharmaceutical Industry

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

Using Multivariate Analysis for Pharmaceutical Drug Product Development

Using Multivariate Analysis for Pharmaceutical Drug Product Development
  • Author : Yifan Wang
  • Publisher : Unknown
  • Release Date : 2016
  • ISBN : OCLC:975363211
DOWNLOAD BOOKUsing Multivariate Analysis for Pharmaceutical Drug Product Development

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,

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
  • ISBN : 9781420056457
DOWNLOAD BOOKStatistics In the Pharmaceutical Industry

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

Pharmaceutical Quality by Design

Pharmaceutical Quality by Design
  • Author : Walkiria S. Schlindwein,Mark Gibson
  • Publisher : John Wiley & Sons
  • Release Date : 2018-01-05
  • ISBN : 9781118895214
DOWNLOAD BOOKPharmaceutical Quality by Design

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

Comprehensive Chemometrics

Comprehensive Chemometrics
  • Author : Steven Brown,Roma Tauler,Beata Walczak
  • Publisher : Elsevier
  • Release Date : 2020-05-26
  • ISBN : 9780444641663
DOWNLOAD BOOKComprehensive Chemometrics

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

Chemical Engineering in the Pharmaceutical Industry, Active Pharmaceutical Ingredients

Chemical Engineering in the Pharmaceutical Industry, Active Pharmaceutical Ingredients
  • Author : David J. am Ende,Mary T. am Ende
  • Publisher : Wiley
  • Release Date : 2019-04-23
  • ISBN : 9781119285861
DOWNLOAD BOOKChemical Engineering in the Pharmaceutical Industry, Active Pharmaceutical Ingredients

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

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture
  • Author : Gintaras V. Reklaitis
  • Publisher : John Wiley & Sons
  • Release Date : 2017-10-09
  • ISBN : 9780470942376
DOWNLOAD BOOKComprehensive Quality by Design for Pharmaceutical Product Development and Manufacture

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

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
  • ISBN : 9780128026373
DOWNLOAD BOOKDeveloping Solid Oral Dosage Forms

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

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
  • ISBN : 9781439829455
DOWNLOAD BOOKPAT Applied in Biopharmaceutical Process Development And Manufacturing

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

Studies in Natural Products Chemistry

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  • Author : Atta-ur-Rahman
  • Publisher : Elsevier
  • Release Date : 2022-08-01
  • ISBN : 9780323911009
DOWNLOAD BOOKStudies in Natural Products Chemistry

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.