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Statistics for Biotechnology Process Development

Statistics for Biotechnology Process Development PDF Author: Todd Coffey
Publisher:
ISBN: 9781315120034
Category : Electronic books
Languages : en
Pages :

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Book Description
"The use of statistics in process development is increasing throughout the biotechnology industry, due in part to an FDA mandate demanding the increased use of statistical concepts, the recognition of the importance of statistics, and the availability of powerful and user-friendly software. This book gives an overview of statistical methods for biotechnology process development, with an emphasis on application and minimal theoretical details. Examples using real data and case studies with JMP software are used throughout to illustrate topics."--Provided by publisher.

Statistics for Biotechnology Process Development

Statistics for Biotechnology Process Development PDF Author: Todd Coffey
Publisher:
ISBN: 9781315120034
Category : Electronic books
Languages : en
Pages :

View

Book Description
"The use of statistics in process development is increasing throughout the biotechnology industry, due in part to an FDA mandate demanding the increased use of statistical concepts, the recognition of the importance of statistics, and the availability of powerful and user-friendly software. This book gives an overview of statistical methods for biotechnology process development, with an emphasis on application and minimal theoretical details. Examples using real data and case studies with JMP software are used throughout to illustrate topics."--Provided by publisher.

Statistics for Biotechnology Process Development

Statistics for Biotechnology Process Development PDF Author: Todd Coffey
Publisher: CRC Press
ISBN: 1498721419
Category : Mathematics
Languages : en
Pages : 346

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Book Description
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.

Statistics for Biotechnology Process Development

Statistics for Biotechnology Process Development PDF Author: Taylor & Francis Group
Publisher: CRC Press
ISBN: 9780367657222
Category :
Languages : en
Pages : 346

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Book Description
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.

Data Science, AI, and Machine Learning in Drug Development

Data Science, AI, and Machine Learning in Drug Development PDF Author: Harry Yang
Publisher: CRC Press
ISBN: 100065267X
Category : Business & Economics
Languages : en
Pages : 335

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Book Description
The confluence of big data, artificial intelligence (AI), and machine learning (ML) has led to a paradigm shift in how innovative medicines are developed and healthcare delivered. To fully capitalize on these technological advances, it is essential to systematically harness data from diverse sources and leverage digital technologies and advanced analytics to enable data-driven decisions. Data science stands at a unique moment of opportunity to lead such a transformative change. Intended to be a single source of information, Data Science, AI, and Machine Learning in Drug Research and Development covers a wide range of topics on the changing landscape of drug R & D, emerging applications of big data, AI and ML in drug development, and the build of robust data science organizations to drive biopharmaceutical digital transformations. Features Provides a comprehensive review of challenges and opportunities as related to the applications of big data, AI, and ML in the entire spectrum of drug R & D Discusses regulatory developments in leveraging big data and advanced analytics in drug review and approval Offers a balanced approach to data science organization build Presents real-world examples of AI-powered solutions to a host of issues in the lifecycle of drug development Affords sufficient context for each problem and provides a detailed description of solutions suitable for practitioners with limited data science expertise

Bayesian Analysis with R for Drug Development

Bayesian Analysis with R for Drug Development PDF Author: Harry Yang
Publisher: CRC Press
ISBN: 1351585940
Category : Mathematics
Languages : en
Pages : 310

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Book Description
Drug development is an iterative process. The recent publications of regulatory guidelines further entail a lifecycle approach. Blending data from disparate sources, the Bayesian approach provides a flexible framework for drug development. Despite its advantages, the uptake of Bayesian methodologies is lagging behind in the field of pharmaceutical development. Written specifically for pharmaceutical practitioners, Bayesian Analysis with R for Drug Development: Concepts, Algorithms, and Case Studies, describes a wide range of Bayesian applications to problems throughout pre-clinical, clinical, and Chemistry, Manufacturing, and Control (CMC) development. Authored by two seasoned statisticians in the pharmaceutical industry, the book provides detailed Bayesian solutions to a broad array of pharmaceutical problems. Features Provides a single source of information on Bayesian statistics for drug development Covers a wide spectrum of pre-clinical, clinical, and CMC topics Demonstrates proper Bayesian applications using real-life examples Includes easy-to-follow R code with Bayesian Markov Chain Monte Carlo performed in both JAGS and Stan Bayesian software platforms Offers sufficient background for each problem and detailed description of solutions suitable for practitioners with limited Bayesian knowledge Harry Yang, Ph.D., is Senior Director and Head of Statistical Sciences at AstraZeneca. He has 24 years of experience across all aspects of drug research and development and extensive global regulatory experiences. He has published 6 statistical books, 15 book chapters, and over 90 peer-reviewed papers on diverse scientific and statistical subjects, including 15 joint statistical works with Dr. Novick. He is a frequent invited speaker at national and international conferences. He also developed statistical courses and conducted training at the FDA and USP as well as Peking University. Steven Novick, Ph.D., is Director of Statistical Sciences at AstraZeneca. He has extensively contributed statistical methods to the biopharmaceutical literature. Novick is a skilled Bayesian computer programmer and is frequently invited to speak at conferences, having developed and taught courses in several areas, including drug-combination analysis and Bayesian methods in clinical areas. Novick served on IPAC-RS and has chaired several national statistical conferences.

Nonclinical Statistics for Pharmaceutical and Biotechnology Industries

Nonclinical Statistics for Pharmaceutical and Biotechnology Industries PDF Author: Lanju Zhang
Publisher: Springer
ISBN: 3319235583
Category : Medical
Languages : en
Pages : 698

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Book Description
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.

Bayesian Methods in Pharmaceutical Research

Bayesian Methods in Pharmaceutical Research PDF Author: Emmanuel Lesaffre
Publisher: CRC Press
ISBN: 1351718665
Category : Medical
Languages : en
Pages : 561

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Book Description
Since the early 2000s, there has been increasing interest within the pharmaceutical industry in the application of Bayesian methods at various stages of the research, development, manufacturing, and health economic evaluation of new health care interventions. In 2010, the first Applied Bayesian Biostatistics conference was held, with the primary objective to stimulate the practical implementation of Bayesian statistics, and to promote the added-value for accelerating the discovery and the delivery of new cures to patients. This book is a synthesis of the conferences and debates, providing an overview of Bayesian methods applied to nearly all stages of research and development, from early discovery to portfolio management. It highlights the value associated with sharing a vision with the regulatory authorities, academia, and pharmaceutical industry, with a view to setting up a common strategy for the appropriate use of Bayesian statistics for the benefit of patients. The book covers: Theory, methods, applications, and computing Bayesian biostatistics for clinical innovative designs Adding value with Real World Evidence Opportunities for rare, orphan diseases, and pediatric development Applied Bayesian biostatistics in manufacturing Decision making and Portfolio management Regulatory perspective and public health policies Statisticians and data scientists involved in the research, development, and approval of new cures will be inspired by the possible applications of Bayesian methods covered in the book. The methods, applications, and computational guidance will enable the reader to apply Bayesian methods in their own pharmaceutical research.

Understanding Economic Statistics: An OECD Perspective

Understanding Economic Statistics: An OECD Perspective PDF Author: OECD
Publisher: OECD Publishing
ISBN: 9264046984
Category :
Languages : en
Pages : 196

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Book Description
Drawing on OECD statistics in particular, ‘Understanding Economic Statistics: an OECD perspective' shows readers how to use statistics to understand the world economy. It gives an overview of the history, key concepts and the main providers of economic statistics.

OECD Glossary of Statistical Terms

OECD Glossary of Statistical Terms PDF Author: OECD
Publisher: OECD Publishing
ISBN: 9264055088
Category :
Languages : en
Pages : 602

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Book Description
The OECD Glossary contains a comprehensive set of over 6 700 definitions of key terminology, concepts and commonly used acronyms derived from existing international statistical guidelines and recommendations.

The Gene Revolution and Global Food Security

The Gene Revolution and Global Food Security PDF Author: B. Oyelaran-Oyeyinka
Publisher: Springer
ISBN: 0230277993
Category : Business & Economics
Languages : en
Pages : 237

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Book Description
Using the concept of innovation capacity, this book, using recent field data from countries in Asia and Africa, competently demonstrates how biotechnology can contribute to sustainable economic development. The approach articulates the imperative for developing countries to build up specific capabilities backed up by policies and institutions.