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Nonclinical Statistics For Pharmaceutical And Biotechnology Industries
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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 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 402 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 Emerging Non-Clinical Biostatistics in Biopharmaceutical Development and Manufacturing by : Harry Yang
Download or read book Emerging Non-Clinical Biostatistics in Biopharmaceutical Development and Manufacturing written by Harry Yang and published by CRC Press. This book was released on 2016-11-30 with total page 278 pages. Available in PDF, EPUB and Kindle. Book excerpt: The premise of Quality by Design (QbD) is that the quality of the pharmaceutical product should be based upon a thorough understanding of both the product and the manufacturing process. This state-of-the-art book provides a single source of information on emerging statistical approaches to QbD and risk-based pharmaceutical development. A comprehensive resource, it combines in-depth explanations of advanced statistical methods with real-life case studies that illustrate practical applications of these methods in QbD implementation.
Book Synopsis The Application of Statistical Process Control in the Pharmaceutical and Biotechnology Industries by : Tom Cochrane
Download or read book The Application of Statistical Process Control in the Pharmaceutical and Biotechnology Industries written by Tom Cochrane and published by Biohealthcare Pub. This book was released on 2012-12-30 with total page 220 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a practical guide on how to apply statistical process control or SPC within the pharmaceutical industry. The book considers the various areas where SPC thinking can be applied and demonstrates the benefits that can be achieved by its use.
Book Synopsis Encyclopedia of Biopharmaceutical Statistics, Second Edition by : Shein-Chung Chow
Download or read book Encyclopedia of Biopharmaceutical Statistics, Second Edition written by Shein-Chung Chow and published by CRC Press. This book was released on 2003-06-04 with total page 1000 pages. Available in PDF, EPUB and Kindle. Book excerpt: The only encyclopedia that specifically focuses on biopharmaceutical statistics, the 3rd Edition provides a well-balanced summary of current regulatory requirements, along with a comprehensive and unified presentation of designs and analyses used at different stages of biopharmaceutical and clinical research and development. This is the definitive statistical guide for the entire pipeline of drug/pharmaceutical product development: from non-clinical and pre-clinical assessments and manufacturing processes through to clinical trials, regulatory processes and postmarketing surveillence. Thoroughly exploring emerging technologies, concepts, and trends, this edition incorporates 89 brand new chapters on subjects such as biomarker development, target clinical trials and follow-on biologics. Previous contents of this title have been revised and updated, and cover topics ranging from in vitro bioequivalence testing and dissolution profile comparison to bridging studies, MedDRA, vaccine clinical trials and medical devices. The encyclopedia also includes popular topics that are currently under discussion within regulatory agencies and the pharmaceutical/biotech industry, such as pharmacoeconomics, reproducibility and probability in clinical research. Available in hard copy and online formats, this highly specialised book is a must-have resource for pharmaceutical R&D departments as well as for statisticians and researchers who work on clinical trials regulated by the FDA.
Book Synopsis Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry by : Richard K. Burdick
Download or read book Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry written by Richard K. Burdick and published by Springer. This book was released on 2017-02-14 with total page 379 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book examines statistical techniques that are critically important to Chemistry, Manufacturing, and Control (CMC) activities. Statistical methods are presented with a focus on applications unique to the CMC in the pharmaceutical industry. The target audience consists of statisticians and other scientists who are responsible for performing statistical analyses within a CMC environment. Basic statistical concepts are addressed in Chapter 2 followed by applications to specific topics related to development and manufacturing. The mathematical level assumes an elementary understanding of statistical methods. The ability to use Excel or statistical packages such as Minitab, JMP, SAS, or R will provide more value to the reader. The motivation for this book came from an American Association of Pharmaceutical Scientists (AAPS) short course on statistical methods applied to CMC applications presented by four of the authors. One of the course participants asked us for a good reference book, and the only book recommended was written over 20 years ago by Chow and Liu (1995). We agreed that a more recent book would serve a need in our industry. Since we began this project, an edited book has been published on the same topic by Zhang (2016). The chapters in Zhang discuss statistical methods for CMC as well as drug discovery and nonclinical development. We believe our book complements Zhang by providing more detailed statistical analyses and examples.
Book Synopsis Bayesian Methods in Pharmaceutical Research by : Emmanuel Lesaffre
Download or read book Bayesian Methods in Pharmaceutical Research written by Emmanuel Lesaffre and published by CRC Press. This book was released on 2020-04-15 with total page 561 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Applied Predictive Modeling by : Max Kuhn
Download or read book Applied Predictive Modeling written by Max Kuhn and published by Springer Science & Business Media. This book was released on 2013-05-17 with total page 600 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
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 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 262 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 Biotechnology Operations by : John M. Centanni
Download or read book Biotechnology Operations written by John M. Centanni and published by CRC Press. This book was released on 2016-09-19 with total page 476 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book describes seven areas in the field of biotechnology operations as practiced by biopharmaceutical firms and nonprofit institutions. Revisions focus upon changes that have occurred in several areas over the past six years, with emphasis on regulatory, biomanufacturing, clinical and technical information, along with processes and guidlines that have added to the discipline. Examples are increased for new technical fields such as cell and tissue engineering. Further, illustrations or figures are added to each chapter to emphasize particular points.
Book Synopsis Mathematical and Statistical Skills in the Biopharmaceutical Industry by : Arkadiy Pitman
Download or read book Mathematical and Statistical Skills in the Biopharmaceutical Industry written by Arkadiy Pitman and published by CRC Press. This book was released on 2019-07-15 with total page 247 pages. Available in PDF, EPUB and Kindle. Book excerpt: Mathematical and Statistical Skills in the Biopharmaceutical Industry: A Pragmatic Approach describes a philosophy of efficient problem solving showcased using examples pertinent to the biostatistics function in clinical drug development. It was written to share a quintessence of the authors’ experiences acquired during many years of relevant work in the biopharmaceutical industry. The book will be useful will be useful for biopharmaceutical industry statisticians at different seniority levels and for graduate students who consider a biostatistics-related career in this industry. Features: Describes a system of principles for pragmatic problem solving in clinical drug development. Discusses differences in the work of a biostatistician in small pharma and big pharma. Explains the importance/relevance of statistical programming and data management for biostatistics and necessity for integration on various levels. Describes some useful statistical background that can be capitalized upon in the drug development enterprise. Explains some hot topics and current trends in biostatistics in simple, non-technical terms. Discusses incompleteness of any system of standard operating procedures, rules and regulations. Provides a classification of scoring systems and proposes a novel approach for evaluation of the safety outcome for a completed randomized clinical trial. Presents applications of the problem solving philosophy in a highly problematic transfusion field where many investigational compounds have failed. Discusses realistic planning of open-ended projects.
Book Synopsis SAS for Mixed Models by : Walter W. Stroup
Download or read book SAS for Mixed Models written by Walter W. Stroup and published by SAS Institute. This book was released on 2018-12-12 with total page 608 pages. Available in PDF, EPUB and Kindle. Book excerpt: Discover the power of mixed models with SAS. Mixed models—now the mainstream vehicle for analyzing most research data—are part of the core curriculum in most master’s degree programs in statistics and data science. In a single volume, this book updates both SAS® for Linear Models, Fourth Edition, and SAS® for Mixed Models, Second Edition, covering the latest capabilities for a variety of applications featuring the SAS GLIMMIX and MIXED procedures. Written for instructors of statistics, graduate students, scientists, statisticians in business or government, and other decision makers, SAS® for Mixed Models is the perfect entry for those with a background in two-way analysis of variance, regression, and intermediate-level use of SAS. This book expands coverage of mixed models for non-normal data and mixed-model-based precision and power analysis, including the following topics: Random-effect-only and random-coefficients models Multilevel, split-plot, multilocation, and repeated measures models Hierarchical models with nested random effects Analysis of covariance models Generalized linear mixed models This book is part of the SAS Press program.
Book Synopsis Encyclopedia of Biopharmaceutical Statistics - Four Volume Set by : Shein-Chung Chow
Download or read book Encyclopedia of Biopharmaceutical Statistics - Four Volume Set written by Shein-Chung Chow and published by CRC Press. This book was released on 2018-09-03 with total page 4057 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since the publication of the first edition in 2000, there has been an explosive growth of literature in biopharmaceutical research and development of new medicines. This encyclopedia (1) provides a comprehensive and unified presentation of designs and analyses used at different stages of the drug development process, (2) gives a well-balanced summary of current regulatory requirements, and (3) describes recently developed statistical methods in the pharmaceutical sciences. Features of the Fourth Edition: 1. 78 new and revised entries have been added for a total of 308 chapters and a fourth volume has been added to encompass the increased number of chapters. 2. Revised and updated entries reflect changes and recent developments in regulatory requirements for the drug review/approval process and statistical designs and methodologies. 3. Additional topics include multiple-stage adaptive trial design in clinical research, translational medicine, design and analysis of biosimilar drug development, big data analytics, and real world evidence for clinical research and development. 4. A table of contents organized by stages of biopharmaceutical development provides easy access to relevant topics. About the Editor: Shein-Chung Chow, Ph.D. is currently an Associate Director, Office of Biostatistics, U.S. Food and Drug Administration (FDA). Dr. Chow is an Adjunct Professor at Duke University School of Medicine, as well as Adjunct Professor at Duke-NUS, Singapore and North Carolina State University. Dr. Chow is the Editor-in-Chief of the Journal of Biopharmaceutical Statistics and the Chapman & Hall/CRC Biostatistics Book Series and the author of 28 books and over 300 methodology papers. He was elected Fellow of the American Statistical Association in 1995.
Download or read book Bad Pharma written by Ben Goldacre and published by Macmillan. This book was released on 2014-04 with total page 479 pages. Available in PDF, EPUB and Kindle. Book excerpt: Argues that doctors are deliberately misinformed by profit-seeking pharmaceutical companies that casually withhold information about drug efficacy and side effects, explaining the process of pharmaceutical data manipulation and its global consequences. By the best-selling author of Bad Science.
Book Synopsis Software-assisted Method Development In High Performance Liquid Chromatography by : Szabolcs Fekete
Download or read book Software-assisted Method Development In High Performance Liquid Chromatography written by Szabolcs Fekete and published by World Scientific. This book was released on 2018-08-01 with total page 364 pages. Available in PDF, EPUB and Kindle. Book excerpt: 'The book is a useful contribution in the field of HPLC, and may represent a valuable tool for chromatography practitioners in different fields, as well as teachers and instructors. The 12 chapters provide comprehensive insights of current day retention and resolution modelling in HPLC, and its applications for small and large molecule analysis. It may be a useful reference for specialists in pharmaceuticals but not limited to … It may be a valuable resource to assist scientists involved in method development, aiming to achieve the best results with reduced costs, time, and efforts.'Analytical and Bioanalytical ChemistryThis handbook gives a general overview of the possibilities in recent developments in chromatographic retention modeling. As a result of the latest developments in modeling software, several new features are now accessible, opening a new level in HPLC method development.Many of these current possibilities in software assisted liquid chromatographic method modeling for analytical purposes are presented. Several modes of chromatography, including Reversed-Phase Liquid Chromatography (RPLC), Ion Exchange Chromatography (IEX), Hydrophobic Interaction Chromatography (HIC), and Hydrophilic Interaction Liquid Chromatography (HILIC) are explained in detail. For all these chromatographic modes, the most important variables for tuning retention and selectivity are exposed.Beside the industrial and practical benefits of retention modeling, the possibilities in teaching and education are also illustrated. Finally, numerous representative industrial examples are shown, to highlight the benefits, time and cost savings offered by state-of-the-art software assisted HPLC method development.
Book Synopsis JMP for Mixed Models by : Ruth Hummel
Download or read book JMP for Mixed Models written by Ruth Hummel and published by SAS Institute. This book was released on 2021-06-09 with total page 380 pages. Available in PDF, EPUB and Kindle. Book excerpt: Discover the power of mixed models with JMP and JMP Pro. Mixed models are now the mainstream method of choice for analyzing experimental data. Why? They are arguably the most straightforward and powerful way to handle correlated observations in designed experiments. Reaching well beyond standard linear models, mixed models enable you to make accurate and precise inferences about your experiments and to gain deeper understanding of sources of signal and noise in the system under study. Well-formed fixed and random effects generalize well and help you make the best data-driven decisions. JMP for Mixed Models brings together two of the strongest traditions in SAS software: mixed models and JMP. JMP’s groundbreaking philosophy of tight integration of statistics with dynamic graphics is an ideal milieu within which to learn and apply mixed models, also known as hierarchical linear or multilevel models. If you are a scientist or engineer, the methods described herein can revolutionize how you analyze experimental data without the need to write code. Inside you’ll find a rich collection of examples and a step-by-step approach to mixed model mastery. Topics include: Learning how to appropriately recognize, set up, and interpret fixed and random effects Extending analysis of variance (ANOVA) and linear regression to numerous mixed model designs Understanding how degrees of freedom work using Skeleton ANOVA Analyzing randomized block, split-plot, longitudinal, and repeated measures designs Introducing more advanced methods such as spatial covariance and generalized linear mixed models Simulating mixed models to assess power and other important sampling characteristics Providing a solid framework for understanding statistical modeling in general Improving perspective on modern dilemmas around Bayesian methods, p-values, and causal inference
