Statistics for Biotechnology Process Development
Statistics for Biotechnology Process Development

Author: Todd Coffey

Publisher: CRC Press

Published: 2018-05-16

Total Pages: 358

ISBN-13: 1498721419

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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

Author: Todd Coffey

Publisher: CRC Press

Published: 2018-05-16

Total Pages: 428

ISBN-13: 1351646346

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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.

Bayesian Analysis with R for Drug Development
Bayesian Analysis with R for Drug Development

Author: Harry Yang

Publisher: CRC Press

Published: 2019-06-26

Total Pages: 310

ISBN-13: 1351585940

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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

Author: Lanju Zhang

Publisher: Springer

Published: 2016-01-13

Total Pages: 705

ISBN-13: 3319235583

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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
Case Studies in Bayesian Methods for Biopharmaceutical CMC

Author: Paul Faya

Publisher: CRC Press

Published: 2022-12-15

Total Pages: 354

ISBN-13: 1000824772

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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
Bayesian Methods in Pharmaceutical Research

Author: Emmanuel Lesaffre

Publisher: CRC Press

Published: 2020-04-15

Total Pages: 583

ISBN-13: 1351718665

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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.

Industrialization of Biology
Industrialization of Biology

Author: National Research Council

Publisher: National Academies Press

Published: 2015-06-29

Total Pages: 158

ISBN-13: 0309316553

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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.

Statistical Methods for Six Sigma
Statistical Methods for Six Sigma

Author: Anand M. Joglekar

Publisher: John Wiley & Sons

Published: 2003-09-19

Total Pages: 339

ISBN-13: 0471465372

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A guide to achieving business successes through statistical methods Statistical methods are a key ingredient in providing data-based guidance to research and development as well as to manufacturing. Understanding the concepts and specific steps involved in each statistical method is critical for achieving consistent and on-target performance. Written by a recognized educator in the field, Statistical Methods for Six Sigma: In R&D and Manufacturing is specifically geared to engineers, scientists, technical managers, and other technical professionals in industry. Emphasizing practical learning, applications, and performance improvement, Dr. Joglekar?s text shows today?s industry professionals how to: Summarize and interpret data to make decisions Determine the amount of data to collect Compare product and process designs Build equations relating inputs and outputs Establish specifications and validate processes Reduce risk and cost-of-process control Quantify and reduce economic loss due to variability Estimate process capability and plan process improvements Identify key causes and their contributions to variability Analyze and improve measurement systems This long-awaited guide for students and professionals in research, development, quality, and manufacturing does not presume any prior knowledge of statistics. It covers a large number of useful statistical methods compactly, in a language and depth necessary to make successful applications. Statistical methods in this book include: variance components analysis, variance transmission analysis, risk-based control charts, capability and performance indices, quality planning, regression analysis, comparative experiments, descriptive statistics, sample size determination, confidence intervals, tolerance intervals, and measurement systems analysis. The book also contains a wealth of case studies and examples, and features a unique test to evaluate the reader?s understanding of the subject.

Handbook of Pharmaceutical Biotechnology
Handbook of Pharmaceutical Biotechnology

Author: Jay P Rho

Publisher: CRC Press

Published: 2003-03-31

Total Pages: 214

ISBN-13: 9780789016355

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Stay up to date with changes in the biopharmaceutical products market! With the growth rate of biopharmaceutical products ascending rapidly since the 1980s, the number of biotechnology companies has risen to more than 1200 new businesses in the Unites States alone. This dramatic increase creates a new set of challenges in education, putting demands on teachers and students to keep pace with innovations in terminology and techniques. The Handbook of Pharmaceutical Biotechnology is essential in meeting those challenges. A practical compendium of biotechnology-produced drugs, the Handbook of Pharmaceutical Biotechnology covers general principles of biotechnology and pharmaceuticals, putting usable information in the hands of those who need it most. The book presents descriptions that break down each pharmaceutical product by pharmacology, pharmacokinetics, clinical applications, toxicities, and dosage guidelines. It also reviews prescription products, discussing clinical uses and trials, adverse reactions, and more. Tables, figures, and extensive references add to each comprehensive summary. The Handbook of Pharmaceutical Biotechnology also includes up-to-date information on: monoclonal antibodies (Abciximab, Muromonab-CD3) enzymes and regulators of enzyme activity (Alteplase, clotting factors, Dornase alpha) anticytokines olgonucleotide and gene therapy hematopoietic growth factors (interleukins, interferons, colony stimulating factors, erythropoietin) As the worldwide production and sales of biotechnology-derived pharmaceuticals and diagnostics continues to grow, teachers, students, and clinical pharmacists need to maintain a clear and current understanding of the field. The Handbook of Pharmaceutical Biotechnology presents a thoughtful and thorough guide to keeping pace in this evolving industry.

Introduction to Statistics in Pharmaceutical Clinical Trials
Introduction to Statistics in Pharmaceutical Clinical Trials

Author: Todd A. Durham

Publisher:

Published: 2008-01-01

Total Pages: 226

ISBN-13: 9780853697145

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All students of pharmaceutical sciences and clinical research need a solid knowledge and understanding of the nature, methods, application, and importance of statistics. Introduction to Statistics in Pharmaceutical Clinical Trials is an ideal introduction to statistics presented in the context of clinical trials conducted during pharmaceutical drug development. This novel approach both teaches the computational steps needed to conduct analyses and provides a conceptual understanding of how these analyses provide information that forms the rational basis for decision making throughout the drug development process.