Nonclinical Statistics For Pharmaceutical And Biotechnology Industries

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Nonclinical Statistics for Pharmaceutical and Biotechnology Industries

Lanju Zhang
Nonclinical Statistics for Pharmaceutical and Biotechnology Industries Book PDF

Author : Lanju Zhang
Publisher : Springer
Page : 698 pages
File Size : 43,5 Mb
Release : 2016-01-13
Category : Medical
ISBN : 9783319235585

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Nonclinical Statistics for Pharmaceutical and Biotechnology Industries by Lanju Zhang Pdf

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.

Statistics for Biotechnology Process Development

Todd Coffey,Harry Yang
Statistics for Biotechnology Process Development Book PDF

Author : Todd Coffey,Harry Yang
Publisher : CRC Press
Page : 402 pages
File Size : 55,8 Mb
Release : 2018-05-16
Category : Mathematics
ISBN : 9781351646345

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Statistics for Biotechnology Process Development by Todd Coffey,Harry Yang Pdf

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.

The Application of Statistical Process Control in the Pharmaceutical and Biotechnology Industries

T Cochrane
The Application of Statistical Process Control in the Pharmaceutical and Biotechnology Industries Book PDF

Author : T Cochrane
Publisher : Elsevier
Page : 0 pages
File Size : 46,6 Mb
Release : 2029-01-01
Category : Medical
ISBN : 1908818360

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The Application of Statistical Process Control in the Pharmaceutical and Biotechnology Industries by T Cochrane Pdf

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

Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry

Richard K. Burdick,David J. LeBlond,Lori B. Pfahler,Jorge Quiroz,Leslie Sidor,Kimberly Vukovinsky,Lanju Zhang
Statistical Applications for Chemistry Manufacturing and Controls CMC in the Pharmaceutical Industry Book PDF

Author : Richard K. Burdick,David J. LeBlond,Lori B. Pfahler,Jorge Quiroz,Leslie Sidor,Kimberly Vukovinsky,Lanju Zhang
Publisher : Springer
Page : 379 pages
File Size : 43,6 Mb
Release : 2017-02-14
Category : Medical
ISBN : 9783319501864

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Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry by Richard K. Burdick,David J. LeBlond,Lori B. Pfahler,Jorge Quiroz,Leslie Sidor,Kimberly Vukovinsky,Lanju Zhang Pdf

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.

Industrial Pharmaceutical Biotechnology

Heinrich Klefenz
Industrial Pharmaceutical Biotechnology Book PDF

Author : Heinrich Klefenz
Publisher : Wiley-VCH
Page : 328 pages
File Size : 45,8 Mb
Release : 2002-04-22
Category : Medical
ISBN : UOM:39015055598992

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Industrial Pharmaceutical Biotechnology by Heinrich Klefenz Pdf

This volume focuses on pharmaceutical biotechnology as a key area of life sciences. The complete range of concepts, processes and technologies of biotechnology is applied in modern industrial pharmaceutical research, development and production. The results of genome sequencing and studies of biological-genetic function are combined with chemical, micro-electronic and microsystem technology to produce medical devices and diagnostic biochips. A multitude of biologically active molecules is expanded by additional novel structures created with newly arranged gene clusters and bio-catalytic chemical processes. New organisational structures in the co-operation of institutes, companies and networks enable faster knowledge and product development and immediate application of the results of research and process development. This book is the ideal source of information for scientists and engineers in research and development, for decision-makers in biotech, pharma and chemical corporations, as well as for research institutes, but also for founders of biotech companies and people working for venture capital corporations.

Bayesian Methods in Pharmaceutical Research

Emmanuel Lesaffre,Gianluca Baio,Bruno Boulanger
Bayesian Methods in Pharmaceutical Research Book PDF

Author : Emmanuel Lesaffre,Gianluca Baio,Bruno Boulanger
Publisher : CRC Press
Page : 561 pages
File Size : 44,7 Mb
Release : 2020-04-15
Category : Medical
ISBN : 9781351718660

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Bayesian Methods in Pharmaceutical Research by Emmanuel Lesaffre,Gianluca Baio,Bruno Boulanger Pdf

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.

Pharmaceutical Biotechnology

Daan J. A. Crommelin,Robert D. Sindelar
Pharmaceutical Biotechnology Book PDF

Author : Daan J. A. Crommelin,Robert D. Sindelar
Publisher : CRC Press
Page : 456 pages
File Size : 40,9 Mb
Release : 2002-11-14
Category : Medical
ISBN : 0415285011

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Pharmaceutical Biotechnology by Daan J. A. Crommelin,Robert D. Sindelar Pdf

The field of pharmaceutical biotechnology is evolving rapidly. A whole new arsenal of protein pharmaceuticals is being produced by recombinant techniques for cancer, viral infections, cardiovascular and hereditary disorders, and other diseases. In addition, scientists are confronted with new technologies such as polymerase chain reactions, combinatorial chemistry and gene therapy. This introductory textbook provides extensive coverage of both the basic science and the applications of biotechnology-produced pharmaceuticals, with special emphasis on their clinical use. Pharmaceutical Biotechnology serves as a complete one-stop source for undergraduate pharmacists, and it is valuable for researchers and professionals in the pharmaceutical industry as well.

Case Studies in Bayesian Methods for Biopharmaceutical CMC

Paul Faya,Tony Pourmohamad
Case Studies in Bayesian Methods for Biopharmaceutical CMC Book PDF

Author : Paul Faya,Tony Pourmohamad
Publisher : CRC Press
Page : 354 pages
File Size : 42,5 Mb
Release : 2022-12-15
Category : Mathematics
ISBN : 9781000824773

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Case Studies in Bayesian Methods for Biopharmaceutical CMC by Paul Faya,Tony Pourmohamad Pdf

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 Analysis with R for Drug Development

Harry Yang,Steven Novick
Bayesian Analysis with R for Drug Development Book PDF

Author : Harry Yang,Steven Novick
Publisher : CRC Press
Page : 262 pages
File Size : 51,6 Mb
Release : 2019-06-26
Category : Mathematics
ISBN : 9781351585934

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Bayesian Analysis with R for Drug Development by Harry Yang,Steven Novick Pdf

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.

Mathematical and Statistical Skills in the Biopharmaceutical Industry

Arkadiy Pitman,Oleksandr Sverdlov,L. Bruce Pearce
Mathematical and Statistical Skills in the Biopharmaceutical Industry Book PDF

Author : Arkadiy Pitman,Oleksandr Sverdlov,L. Bruce Pearce
Publisher : CRC Press
Page : 247 pages
File Size : 41,9 Mb
Release : 2019-07-15
Category : Business & Economics
ISBN : 9780429532238

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Mathematical and Statistical Skills in the Biopharmaceutical Industry by Arkadiy Pitman,Oleksandr Sverdlov,L. Bruce Pearce Pdf

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.

SAS for Mixed Models

Walter W. Stroup,George A. Milliken,Elizabeth A. Claassen,Russell D. Wolfinger
SAS for Mixed Models Book PDF

Author : Walter W. Stroup,George A. Milliken,Elizabeth A. Claassen,Russell D. Wolfinger
Publisher : SAS Institute
Page : 608 pages
File Size : 42,6 Mb
Release : 2018-12-12
Category : Computers
ISBN : 9781635261523

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SAS for Mixed Models by Walter W. Stroup,George A. Milliken,Elizabeth A. Claassen,Russell D. Wolfinger Pdf

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.

Biotechnology Operations

John M. Centanni,Michael J. Roy
Biotechnology Operations Book PDF

Author : John M. Centanni,Michael J. Roy
Publisher : CRC Press
Page : 476 pages
File Size : 55,6 Mb
Release : 2016-09-19
Category : Medical
ISBN : 9781498758864

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Biotechnology Operations by John M. Centanni,Michael J. Roy Pdf

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.

Encyclopedia of Biopharmaceutical Statistics - Four Volume Set

Shein-Chung Chow
Encyclopedia of Biopharmaceutical Statistics Four Volume Set Book PDF

Author : Shein-Chung Chow
Publisher : CRC Press
Page : 4057 pages
File Size : 54,7 Mb
Release : 2018-09-03
Category : Medical
ISBN : 9781351110259

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Encyclopedia of Biopharmaceutical Statistics - Four Volume Set by Shein-Chung Chow Pdf

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.

Software-assisted Method Development In High Performance Liquid Chromatography

Szabolcs Fekete,Imre Molnar
Software assisted Method Development In High Performance Liquid Chromatography Book PDF

Author : Szabolcs Fekete,Imre Molnar
Publisher : World Scientific
Page : 364 pages
File Size : 45,5 Mb
Release : 2018-08-01
Category : Science
ISBN : 9781786345479

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Software-assisted Method Development In High Performance Liquid Chromatography by Szabolcs Fekete,Imre Molnar Pdf

'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.

JMP for Mixed Models

Ruth Hummel,Elizabeth A. Claassen,Russell D. Wolfinger
JMP for Mixed Models Book PDF

Author : Ruth Hummel,Elizabeth A. Claassen,Russell D. Wolfinger
Publisher : SAS Institute
Page : 380 pages
File Size : 55,6 Mb
Release : 2021-06-09
Category : Computers
ISBN : 9781952363856

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JMP for Mixed Models by Ruth Hummel,Elizabeth A. Claassen,Russell D. Wolfinger Pdf

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