Nonclinical Statistics For Pharmaceutical And Biotechnology Industries
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| Author | : Lanju Zhang |
| Publisher | : Springer |
| Total Pages | : 705 |
| Release | : 2016-01-13 |
| Genre | : Medical |
| ISBN | : 3319235583 |
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.
| Author | : Jay P Rho |
| Publisher | : CRC Press |
| Total Pages | : 214 |
| Release | : 2003-03-31 |
| Genre | : Medical |
| ISBN | : 9780789016355 |
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.
| Author | : Philip Rowe |
| Publisher | : John Wiley & Sons |
| Total Pages | : 431 |
| Release | : 2015-07-20 |
| Genre | : Medical |
| ISBN | : 1118913418 |
Essential Statistics for the Pharmaceutical Sciences is targeted at all those involved in research in pharmacology, pharmacy or other areas of pharmaceutical science; everybody from undergraduate project students to experienced researchers should find the material they need. This book will guide all those who are not specialist statisticians in using sound statistical principles throughout the whole journey of a research project - designing the work, selecting appropriate statistical methodology and correctly interpreting the results. It deliberately avoids detailed calculation methodology. Its key features are friendliness and clarity. All methods are illustrated with realistic examples from within pharmaceutical science. This edition now includes expanded coverage of some of the topics included in the first edition and adds some new topics relevant to pharmaceutical research. a clear, accessible introduction to the key statistical techniques used within the pharmaceutical sciences all examples set in relevant pharmaceutical contexts. key points emphasised in summary boxes and warnings of potential abuses in ‘pirate boxes’. supplementary material - full data sets and detailed instructions for carrying out analyses using packages such as SPSS or Minitab – provided at: https://www.wiley.com/go/rowe/statspharmascience2e An invaluable introduction to statistics for any science student and an essential text for all those involved in pharmaceutical research at whatever level.
| Author | : Ray Liu |
| Publisher | : |
| Total Pages | : 337 |
| Release | : 2019 |
| Genre | : Mathematical statistics |
| ISBN | : 9783319673875 |
This book presents the proceedings of the 39th annual Midwest Biopharmaceutical Statistics Workshop (MBSW), held in Muncie, Indiana on May 16-18, 2016. It consists of selected peer- reviewed and revised papers on topics ranging from statistical applications in drug discovery and CMC to biomarkers, clinical trials, and statistical programming. All contributions feature original research, and together they cover the full spectrum of pharmaceutical R & D - with a special focus on emergent topics such as biosimilarity, bioequivalence, clinical trial design, and subgroup identification. Founded in 1978, the MBSW has provided a forum for statisticians to share knowledge, research, and applications on key statistical topics in pharmaceutical R & D for almost forty years, with the 2016 conference theme being "The Power and 3 I's of Statistics: Innovation, Impact and Integrity." The papers gathered here will be of interest to all researchers whose work involves the quantitative aspects of pharmaceutical research and development, including pharmaceutical statisticians who want to keep up-to-date with the latest trends, as well as academic statistics researchers looking for areas of application.
| Author | : Wim Jiskoot |
| Publisher | : Springer Science & Business Media |
| Total Pages | : 694 |
| Release | : 2005-12-05 |
| Genre | : Medical |
| ISBN | : 9780971176720 |
Protein pharmaceuticals form a fast-growing category in the arsenal of drugs. This book explores the nature of different analytical techniques and the way in which they are related to pharmaceutical proteins. In addition to serving the analytical chemist, this book is needed by the formulation scientist who is responsible for design and formulation of a pharmaceutical protein that can be monitored during production and over time.
| Author | : Todd Coffey |
| Publisher | : CRC Press |
| Total Pages | : 428 |
| Release | : 2018-05-16 |
| Genre | : Mathematics |
| ISBN | : 1351646346 |
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.
| Author | : Michael J. Welch |
| Publisher | : John Wiley & Sons |
| Total Pages | : 872 |
| Release | : 2003-01-17 |
| Genre | : Medical |
| ISBN | : 9780471495604 |
A comprehensive, authoritative and up-to-date reference for the newcomer to radiopharmaceuticals and those already in the field. Radiopharmaceuticals are used to detect and characterise disease processes, or normal biological function, in living cells, animals or humans. Used as tracer molecules, they map the distribution, uptake and metabolism of the molecule in clinical studies, basic research or applied research. The area of radiopharmaceuticals is expanding rapidly. The number of PET centers in the world is increasing at 20% per year, and many drug companies are utilising PET and other forms of radiopharmaceutical imaging to evaluate products. * Readers will find coverage on a number of important topics such as radionuclide production, PET and drug development, and regulations * Explains how to use radiopharmaceuticals for the diagnosis and therapy of cancer and other diseases * The editors and a majority of the contributors are from the United States
| Author | : Max Kuhn |
| Publisher | : Springer Science & Business Media |
| Total Pages | : 595 |
| Release | : 2013-05-17 |
| Genre | : Medical |
| ISBN | : 1461468493 |
Applied Predictive Modeling covers the overall predictive modeling process, beginning with the crucial steps of data preprocessing, data splitting and foundations of model tuning. The text then provides intuitive explanations of numerous common and modern regression and classification techniques, always with an emphasis on illustrating and solving real data problems. The text illustrates all parts of the modeling process through many hands-on, real-life examples, and every chapter contains extensive R code for each step of the process. This multi-purpose text can be used as an introduction to predictive models and the overall modeling process, a practitioner’s reference handbook, or as a text for advanced undergraduate or graduate level predictive modeling courses. To that end, each chapter contains problem sets to help solidify the covered concepts and uses data available in the book’s R package. This text is intended for a broad audience as both an introduction to predictive models as well as a guide to applying them. Non-mathematical readers will appreciate the intuitive explanations of the techniques while an emphasis on problem-solving with real data across a wide variety of applications will aid practitioners who wish to extend their expertise. Readers should have knowledge of basic statistical ideas, such as correlation and linear regression analysis. While the text is biased against complex equations, a mathematical background is needed for advanced topics.
| Author | : John Jensen |
| Publisher | : |
| Total Pages | : 226 |
| Release | : 2019-06-10 |
| Genre | : Medical |
| ISBN | : 9781632428288 |
Any substance which causes a temporary physiological or psychological change in the body on being consumed, inhaled, smoked or absorbed is called a drug. Pharmaceutical drugs are the chemical substances which are used to prevent, diagnose, cure or treat diseases or to promote well-being. They can be used for limited period or on regular basis according to the diseases. They are produced from medicinal plants or by organic synthesis. The domain of pharmaceutical science is concerned with the design, delivery, disposition and action of such drugs. The topics included in this book on drugs and pharmaceutical sciences are of utmost significance and bound to provide incredible insights to readers. It strives to provide a fair idea about this discipline and to help develop a better understanding of the latest advances within this field. For all those who are interested in drugs and pharmaceutical sciences, this book can prove to be an essential guide.
| Author | : Mingxiu Hu |
| Publisher | : Springer Science & Business Media |
| Total Pages | : 340 |
| Release | : 2013-09-14 |
| Genre | : Medical |
| ISBN | : 1461478464 |
This volume presents 27 selected papers in topics that range from statistical applications in business and finance to applications in clinical trials and biomarker analysis. All papers feature original, peer-reviewed content. The editors intentionally selected papers that cover many topics so that the volume will serve the whole statistical community and a variety of research interests. The papers represent select contributions to the 21st ICSA Applied Statistics Symposium. The International Chinese Statistical Association (ICSA) Symposium took place between the 23rd and 26th of June, 2012 in Boston, Massachusetts. It was co-sponsored by the International Society for Biopharmaceutical Statistics (ISBS) and American Statistical Association (ASA). This is the inaugural proceedings volume to share research from the ICSA Applied Statistics Symposium.
