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Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry

2017-02-14 Medical
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Release : 2017-02-14
Genre : Medical
Kind : eBook
Book Rating : 860/5 ( reviews)

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Book Synopsis Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry by : Richard K. Burdick

Download or read book Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry written by Richard K. Burdick. This book was released on 2017-02-14. Available in PDF, EPUB and Kindle. Book excerpt: This book examines statistical techniques that are critically important to Chemistry, Manufacturing, and Control (CMC) activities. Statistical methods are presented with a focus on applications unique to the CMC in the pharmaceutical industry. The target audience consists of statisticians and other scientists who are responsible for performing statistical analyses within a CMC environment. Basic statistical concepts are addressed in Chapter 2 followed by applications to specific topics related to development and manufacturing. The mathematical level assumes an elementary understanding of statistical methods. The ability to use Excel or statistical packages such as Minitab, JMP, SAS, or R will provide more value to the reader. The motivation for this book came from an American Association of Pharmaceutical Scientists (AAPS) short course on statistical methods applied to CMC applications presented by four of the authors. One of the course participants asked us for a good reference book, and the only book recommended was written over 20 years ago by Chow and Liu (1995). We agreed that a more recent book would serve a need in our industry. Since we began this project, an edited book has been published on the same topic by Zhang (2016). The chapters in Zhang discuss statistical methods for CMC as well as drug discovery and nonclinical development. We believe our book complements Zhang by providing more detailed statistical analyses and examples.

Chemical Engineering in the Pharmaceutical Industry

2011-03-10 Technology & Engineering
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Release : 2011-03-10
Genre : Technology & Engineering
Kind : eBook
Book Rating : 107/5 ( reviews)

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Book Synopsis Chemical Engineering in the Pharmaceutical Industry by : David J. am Ende

Download or read book Chemical Engineering in the Pharmaceutical Industry written by David J. am Ende. This book was released on 2011-03-10. Available in PDF, EPUB and Kindle. Book excerpt: 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 for Biotechnology Process Development

2018-05-16 Mathematics
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Release : 2018-05-16
Genre : Mathematics
Kind : eBook
Book Rating : 419/5 ( reviews)

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Book Synopsis Statistics for Biotechnology Process Development by : Todd Coffey

Download or read book Statistics for Biotechnology Process Development written by Todd Coffey. This book was released on 2018-05-16. Available in PDF, EPUB and Kindle. Book excerpt: Written specifically for biotechnology scientists, engineers, and quality professionals, this book describes and demonstrates the proper application of statistical methods throughout Chemistry, Manufacturing, and Controls (CMC). Filled with case studies, examples, and easy-to-follow explanations of how to perform statistics in modern software, it is the first book on CMC statistics written primarily for practitioners. While statisticians will also benefit from this book, it is written particularly for industry professionals who don’t have access to a CMC statistician or who want to be more independent in the design and analysis of their experiments. Provides an introduction to the statistical concepts important in the biotechnology industry Focuses on concepts with theoretical details kept to a minimum Includes lots of real examples and case studies to illustrate the methods Uses JMP software for implementation of the methods Offers a text suitable for scientists in the industry with some quantitative training Written and edited by seasoned veterans of the biotechnology industry, this book will prove useful to a wide variety of biotechnology professionals. The book brings together individual chapters that showcase the use of statistics in the most salient areas of CMC.

Statistical and Computational Techniques in Manufacturing

2012-03-06 Technology & Engineering
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Release : 2012-03-06
Genre : Technology & Engineering
Kind : eBook
Book Rating : 59X/5 ( reviews)

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Book Synopsis Statistical and Computational Techniques in Manufacturing by : J. Paulo Davim

Download or read book Statistical and Computational Techniques in Manufacturing written by J. Paulo Davim. This book was released on 2012-03-06. Available in PDF, EPUB and Kindle. Book excerpt: In recent years, interest in developing statistical and computational techniques for applied manufacturing engineering has been increased. Today, due to the great complexity of manufacturing engineering and the high number of parameters used, conventional approaches are no longer sufficient. Therefore, in manufacturing, statistical and computational techniques have achieved several applications, namely, modelling and simulation manufacturing processes, optimization manufacturing parameters, monitoring and control, computer-aided process planning, etc. The present book aims to provide recent information on statistical and computational techniques applied in manufacturing engineering. The content is suitable for final undergraduate engineering courses or as a subject on manufacturing at the postgraduate level. This book serves as a useful reference for academics, statistical and computational science researchers, mechanical, manufacturing and industrial engineers, and professionals in industries related to manufacturing engineering.

Nonclinical Statistics for Pharmaceutical and Biotechnology Industries

2016-01-13 Medical
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Release : 2016-01-13
Genre : Medical
Kind : eBook
Book Rating : 583/5 ( reviews)

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Book Synopsis Nonclinical Statistics for Pharmaceutical and Biotechnology Industries by : Lanju Zhang

Download or read book Nonclinical Statistics for Pharmaceutical and Biotechnology Industries written by Lanju Zhang. This book was released on 2016-01-13. Available in PDF, EPUB and Kindle. Book excerpt: This book serves as a reference text for regulatory, industry and academic statisticians and also a handy manual for entry level Statisticians. Additionally it aims to stimulate academic interest in the field of Nonclinical Statistics and promote this as an important discipline in its own right. This text brings together for the first time in a single volume a comprehensive survey of methods important to the nonclinical science areas within the pharmaceutical and biotechnology industries. Specifically the Discovery and Translational sciences, the Safety/Toxiology sciences, and the Chemistry, Manufacturing and Controls sciences. Drug discovery and development is a long and costly process. Most decisions in the drug development process are made with incomplete information. The data is rife with uncertainties and hence risky by nature. This is therefore the purview of Statistics. As such, this book aims to introduce readers to important statistical thinking and its application in these nonclinical areas. The chapters provide as appropriate, a scientific background to the topic, relevant regulatory guidance, current statistical practice, and further research directions.

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