Read Books Online and Download eBooks, EPub, PDF, Mobi, Kindle, Text Full Free.
Statistics For Biotechnology Process Development
Download Statistics For Biotechnology Process Development full books in PDF, epub, and Kindle. Read online Statistics For Biotechnology Process Development ebook anywhere anytime directly on your device. Fast Download speed and no annoying ads. We cannot guarantee that every ebooks is available!
Book Synopsis Statistics for Biotechnology Process Development by : Todd Coffey
Download or read book Statistics for Biotechnology Process Development written by Todd Coffey and published by . This book was released on 2017 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: "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.
Book Synopsis Statistics for Biotechnology Process Development by : Taylor & Francis Group
Download or read book Statistics for Biotechnology Process Development written by Taylor & Francis Group and published by CRC Press. This book was released on 2020-09-30 with total page 346 pages. 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.
Book Synopsis Statistics for Biotechnology Process Development by : Todd Coffey
Download or read book Statistics for Biotechnology Process Development written by Todd Coffey and published by CRC Press. This book was released on 2018-05-16 with total page 358 pages. 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.
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 and published by Springer. This book was released on 2016-01-13 with total page 698 pages. 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.
Book Synopsis Process Monitoring and Quality by Design for Biotechnology Products by : Neslihan Delacruz
Download or read book Process Monitoring and Quality by Design for Biotechnology Products written by Neslihan Delacruz and published by Biota Publishing. This book was released on 2010-09-01 with total page 38 pages. Available in PDF, EPUB and Kindle. Book excerpt: Traditional pharmaceutical development is an unwieldy process requiring extensive experimentation and long lead times before process scientists can fully understand the effect that process parameters such as pH, temperature, cell viability, or process yield may have on the product acceptability. Implementation of quality by design is a science-based approach that allows the operating ranges and the acceptance criteria to be established based on the impact on product quality attributes. During manufacturing, process monitoring becomes part of a continuous verification effort and statistical control limits can be used to signal potential trends or drifts in the process. Single manufacturing batches that are aberrant are readily identified. The melding of scientific understanding, information systems architecture, instrumentation, software, and personnel training provides a large return on investment by ensuring that the manufacturing process produces a consistent pharmaceutical product that meets acceptable release standards for human use. Table of Contents: Abbreviations / Introduction / From the Traditional Development Path to Quality by Design / Continuous Process Verification and Process Monitoring / Process Monitoring and Statistical Control Limits / Multivariate Analysis: A Mature State of Statistical Process Monitoring / Conclusion / Bibliography
Book Synopsis Statistics in Food and Biotechnology by : Gerhard Schleining
Download or read book Statistics in Food and Biotechnology written by Gerhard Schleining and published by Springer. This book was released on 2024-03-15 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The proper use of statistical methods is essential in food processing and biotechnology, and very few publications have focused on the practical application of these methods. This book utilizes case studies to explain the corresponding basics with a focus on understanding how and when to use the appropriate statistical methods. The text is structured according to practical applications, starting from data collection and data treatment, moving to product development, process control and analytical methods. Practical Examples of Using Statistics in Food and Biotechnology begins with a detailed introduction to statistics and their use in food processing. The first main section focuses on statistics for data collection and treatment featuring scales of measurement, sampling and summarizing and presenting data. Another section looks at statistics for food product and process development, examining mixture experiments for different food groups from meat and fish to vegetables, juices, rice and olive oils. Further sections focus on statistical process control, statistics for sensory science and a wide range of analytical methods including LC-MS/MS and other cutting edge methods. In providing practical, hands-on information on the use of statistics in food processing, this work will be of major importance for food professionals, industry staff and researchers in food and biotechnology. .
Book Synopsis Bayesian Analysis with R for Drug Development by : Harry Yang
Download or read book Bayesian Analysis with R for Drug Development written by Harry Yang and published by CRC Press. This book was released on 2019-06-26 with total page 310 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Case Studies in Bayesian Methods for Biopharmaceutical CMC by : Paul Faya
Download or read book Case Studies in Bayesian Methods for Biopharmaceutical CMC written by Paul Faya and published by CRC Press. This book was released on 2022-12-15 with total page 354 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Book Synopsis The Application of Statistical Process Control in the Pharmaceutical and Biotechnology Industries by : T Cochrane
Download or read book The Application of Statistical Process Control in the Pharmaceutical and Biotechnology Industries written by T Cochrane and published by Elsevier. This book was released on 2029-01-01 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Innovative new technology now allows the measurement and collection of data throughout many manufacturing processes previously unavailable. The The Application of Statistical Process Control in the Pharmaceutical and Biotechnology Industries is a starting point for anyone who has been tasked to use technology to measure and collect data to gain an understanding of their processes in order to improve and control lengthy, complex supply chains in the pharmaceutical industry. It is a practical guide on how to apply statistical process control (SPC) within the pharmaceutical industry. It encourages all those involved in the industry - whether it be production, quality or the regulatory bodies - to start assessing data in a different way. This book delivers a way of viewing data that is both simple and easy to understand and relates to our understanding of the world in which we work. The first book to describe SPC in the pharmaceutical and biotechnology industries Highly practical approach Contains many case studies showing the application of SPC
Book Synopsis Biotechnology Research and Development Activities in Industry by :
Download or read book Biotechnology Research and Development Activities in Industry written by and published by . This book was released on 1984 with total page 40 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis The Gene Revolution and Global Food Security by : B. Oyelaran-Oyeyinka
Download or read book The Gene Revolution and Global Food Security written by B. Oyelaran-Oyeyinka and published by Springer. This book was released on 2009-11-30 with total page 237 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis OECD Glossary of Statistical Terms by : OECD
Download or read book OECD Glossary of Statistical Terms written by OECD and published by OECD Publishing. This book was released on 2008-09-01 with total page 602 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Industrialization of Biology by : National Research Council
Download or read book Industrialization of Biology written by National Research Council and published by National Academies Press. This book was released on 2015-06-29 with total page 167 pages. Available in PDF, EPUB and Kindle. Book excerpt: The tremendous progress in biology over the last half century - from Watson and Crick's elucidation of the structure of DNA to today's astonishing, rapid progress in the field of synthetic biology - has positioned us for significant innovation in chemical production. New bio-based chemicals, improved public health through improved drugs and diagnostics, and biofuels that reduce our dependency on oil are all results of research and innovation in the biological sciences. In the past decade, we have witnessed major advances made possible by biotechnology in areas such as rapid, low-cost DNA sequencing, metabolic engineering, and high-throughput screening. The manufacturing of chemicals using biological synthesis and engineering could expand even faster. A proactive strategy - implemented through the development of a technical roadmap similar to those that enabled sustained growth in the semiconductor industry and our explorations of space - is needed if we are to realize the widespread benefits of accelerating the industrialization of biology. Industrialization of Biology presents such a roadmap to achieve key technical milestones for chemical manufacturing through biological routes. This report examines the technical, economic, and societal factors that limit the adoption of bioprocessing in the chemical industry today and which, if surmounted, would markedly accelerate the advanced manufacturing of chemicals via industrial biotechnology. Working at the interface of synthetic chemistry, metabolic engineering, molecular biology, and synthetic biology, Industrialization of Biology identifies key technical goals for next-generation chemical manufacturing, then identifies the gaps in knowledge, tools, techniques, and systems required to meet those goals, and targets and timelines for achieving them. This report also considers the skills necessary to accomplish the roadmap goals, and what training opportunities are required to produce the cadre of skilled scientists and engineers needed.
Book Synopsis Development of Gene Therapies by : Avery McIntosh
Download or read book Development of Gene Therapies written by Avery McIntosh and published by CRC Press. This book was released on 2024-05-23 with total page 490 pages. Available in PDF, EPUB and Kindle. Book excerpt: Cell and gene therapies have become the third major drug modality in pharmaceutical medicine of the 21st century after low molecular weight and antibody drugs. The gene therapy (GTx) field is rapidly advancing, and yet there are still fundamental scientific questions that remain to be answered. Development of GTx products poses unique challenges and opportunities for drug developers. However, there is lack of a systematic exposition of the GTx product development and the pivotal role of the biostatistician in this process. Development of Gene Therapies: Strategic, Scientific, and Regulatory, and Access Considerations attempts to summarize the current state-of-the-art strategic, scientific, statistical, and regulatory aspects of GTx development. Intended to provide an exposition to the GTx new product development through peer-reviewed papers written by subject matter experts in this emerging field, this book will be useful for researchers in gene therapy drug development, biostatisticians, regulators, patient advocates, graduate students, and the finance and business development community . Key Features: A collection of papers covering a wide spectrum of topics in gene therapies (GTx), written by leading subject matter experts An exposition of the core principles of GTx product development, emerging business models, industry standards, best practices, and regulatory pathways An exposition of statistical and innovative modeling tools for design and analysis of clinical trials of GTx Insights into commercial models, access hurdles, and health economics of gene therapies Case studies of successful GTx approvals from core team members that developed the first two FDA-approved AAV gene therapies: Luxturna and Zolgensma A discussion of potential benefits and hurdles to be overcome for GTx in coming years from a multi-stakeholder perspective
Download or read book Digital Twins written by Christoph Herwig and published by Springer Nature. This book was released on 2021-05-27 with total page 262 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the first of two volumes that together provide an overview of the latest advances in the generation and application of digital twins in bioprocess design and optimization. Both processes have undergone significant changes over the past few decades, moving from data-driven approaches into the 21st-century digitalization of the bioprocess industry. Moreover, the high demand for biotechnological products calls for efficient methods during research and development, as well as during tech transfer and routine manufacturing. In this regard, one promising tool is the use of digital twins, which offer a virtual representation of the bioprocess. They reflect the mechanistics of the biological system and the interactions between process parameters, key performance indicators and product quality attributes in the form of a mathematical process model. Furthermore, digital twins allow us to use computer-aided methods to gain an improved process understanding, to test and plan novel bioprocesses, and to efficiently monitor them. This book explains the mathematical structure of digital twins, their development and the model’s respective parts, as well as concepts for the knowledge-driven generation and structural variability of digital twins. Covering fundamentals as well as applications, the two volumes offer the ideal introduction to the topic for researchers in academy and industry alike.
Book Synopsis Biotechnology Statistics in OECD Member Countries by : Brigitte van Beuzekom
Download or read book Biotechnology Statistics in OECD Member Countries written by Brigitte van Beuzekom and published by . This book was released on 2000 with total page 86 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309452058 Total Pages :231 pages Book Rating :4.3/5 (94 download)
Book Synopsis Preparing for Future Products of Biotechnology by : National Academies of Sciences, Engineering, and Medicine
Download or read book Preparing for Future Products of Biotechnology written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-07-28 with total page 231 pages. Available in PDF, EPUB and Kindle. Book excerpt: Between 1973 and 2016, the ways to manipulate DNA to endow new characteristics in an organism (that is, biotechnology) have advanced, enabling the development of products that were not previously possible. What will the likely future products of biotechnology be over the next 5â€"10 years? What scientific capabilities, tools, and/or expertise may be needed by the regulatory agencies to ensure they make efficient and sound evaluations of the likely future products of biotechnology? Preparing for Future Products of Biotechnology analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making. This report identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of biotechnology are well understood.
