Statistics For Biotechnology Process Development
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Statistics For Biotechnology Process Development
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Author : Todd Coffey
language : en
Publisher: CRC Press
Release Date : 2018-05-16
Statistics For Biotechnology Process Development written by Todd Coffey and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-05-16 with Mathematics categories.
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.
Biostatistics For Bioassay
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Author : Ann Yellowlees
language : en
Publisher: CRC Press
Release Date : 2024-12-24
Biostatistics For Bioassay written by Ann Yellowlees and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-12-24 with Mathematics categories.
In recent decades, there has been enormous growth in biologics research and development, with the accompanying development of biological assays for emerging products. In parallel, there have been substantial advances in statistical methodology, as well as technological advances in computer power, enabling new techniques to be implemented via statistical software. Biostatistics for Bioassay presents an overview of the statistical analysis techniques that are needed in order to report the results of biological assays. These assays are needed for testing all biological medicines, such as vaccines and cell therapies, to allow them to be released for use. Beginning with consideration of the performance characteristics required of a bioassay, including accuracy, precision, and combinations of these two attributes, the book builds a framework for statistical bioassay design. Features: Explains the statistical methods needed at each stage of the lifecycle of a bioassay Describes the demonstration of the bioassay’s performance, known as validation Covers the statistical techniques for monitoring the bioassay’s performance over time Details how to transfer the bioassay to another laboratory or replace critical reagents Provides examples at every stage, to allow the reader to work through the techniques and consolidate their understanding The book provides a resource for interested bioassay analysts, and statisticians working with bioassays. In bringing together best practices in statistics across the bioassay lifecycle into a single volume, it aims to provide a comprehensive and useful textbook for statistical analysis in bioassay.
Bayesian Analysis With R For Drug Development
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Author : Harry Yang
language : en
Publisher: CRC Press
Release Date : 2019-06-26
Bayesian Analysis With R For Drug Development written by Harry Yang and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-06-26 with Mathematics categories.
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
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Author : Lanju Zhang
language : en
Publisher: Springer
Release Date : 2016-01-13
Nonclinical Statistics For Pharmaceutical And Biotechnology Industries written by Lanju Zhang and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-01-13 with Medical categories.
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.
Case Studies In Bayesian Methods For Biopharmaceutical Cmc
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Author : Paul Faya
language : en
Publisher: CRC Press
Release Date : 2022-12-15
Case Studies In Bayesian Methods For Biopharmaceutical Cmc written by Paul Faya and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-12-15 with Mathematics categories.
The subject of this book is applied Bayesian methods for chemistry, manufacturing, and control (CMC) studies in the biopharmaceutical industry. The book has multiple authors from industry and academia, each contributing a case study (chapter). The collection of case studies covers a broad array of CMC topics, including stability analysis, analytical method development, specification setting, process development and optimization, process control, experimental design, dissolution testing, and comparability studies. The analysis of each case study includes a presentation of code and reproducible output. This book is written with an academic level aimed at practicing nonclinical biostatisticians, most of whom have graduate degrees in statistics. • First book of its kind focusing strictly on CMC Bayesian case studies • Case studies with code and output • Representation from several companies across the industry as well as academia • Authors are leading and well-known Bayesian statisticians in the CMC field • Accompanying website with code for reproducibility • Reflective of real-life industry applications/problems
Bayesian Methods In Pharmaceutical Research
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Author : Emmanuel Lesaffre
language : en
Publisher: CRC Press
Release Date : 2020-04-15
Bayesian Methods In Pharmaceutical Research written by Emmanuel Lesaffre and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-04-15 with Medical categories.
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.
Specification Of Drug Substances And Products
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Author : Christopher M. Riley
language : en
Publisher: Elsevier
Release Date : 2020-07-23
Specification Of Drug Substances And Products written by Christopher M. Riley and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-07-23 with Science categories.
Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, presents a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development, validation of analytical methods, and their application in practice. This thoroughly revised second edition covers topics not covered or not substantially covered in the first edition, including method development and validation in the clinical phase, method transfer, process analytical technology, analytical life cycle management, special challenges with generic drugs, genotoxic impurities, topical products, nasal sprays and inhalation products, and biotechnology products. The book's authors have been carefully selected as former members of the ICH Expert Working Groups charged with developing the ICH guidelines, and/or subject-matter experts in the industry, academia and in government laboratories. - Presents a critical assessment of the application of ICH guidelines on method validation and specification setting - Written by subject-matter experts involved in the development and application of the guidelines - Provides a comprehensive treatment of the analytical methodologies used in the analysis, control and specification of new drug substances and products - Covers the latest statistical approaches (including analytical quality by design) in the development of specifications, method validation and shelf-life prediction
Understanding Economic Statistics An Oecd Perspective
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Author : OECD
language : en
Publisher: OECD Publishing
Release Date : 2008-10-08
Understanding Economic Statistics An Oecd Perspective written by OECD and has been published by OECD Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-10-08 with categories.
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
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Author : OECD
language : en
Publisher: OECD Publishing
Release Date : 2008-09-01
Oecd Glossary Of Statistical Terms written by OECD and has been published by OECD Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-09-01 with categories.
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
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Author : B. Oyelaran-Oyeyinka
language : en
Publisher: Springer
Release Date : 2009-11-30
The Gene Revolution And Global Food Security written by B. Oyelaran-Oyeyinka and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-11-30 with Business & Economics categories.
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.