Statistical Methods For Pharmaceutical Research Planning
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Statistical Methods for Pharmaceutical Research Planning by S. W. Bergman Pdf
This book focuses on statistical methods which impinge more or less directly on the decisions that are made during the course of pharmaceutical and agro-chemical research, considering the four decision-making areas.
Statistical Methodology in the Pharmaceutical Sciences by D. A. Berry Pdf
A state-of-the-art handbook of statistical analysis for use in the pharmaceutical industry. Areas covered in this reference/text include: bioavailability, repeated-measures designs, dose-response, population models, multicenter trials, handling dropouts, survival analysis, robust data analysis, cate
Applied Statistics in the Pharmaceutical Industry by Steven P. Millard,Andreas Krause Pdf
Providing a general guide to statistical methods used in the pharmaceutical industry, and illustrating how to use S-PLUS to implement these methods, the book explains why S-PLUS is a useful software package and discusses the results and implications of each particular application. It is targeted at graduates in biostatistics, statisticians involved in the industry as research scientists, regulators, academics, and/or consultants who want to know more about how to use S-PLUS and learn about other sub-fields within the industry, as well as statisticians in other fields who want to know more about statistical applications in the pharmaceutical industry.
Introduction to Statistics in Pharmaceutical Clinical Trials by Todd A. Durham,J. Rick Turner Pdf
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.
Statistical Design and Analysis in Pharmaceutical Science by Shein-Chung Chow,Jen-pei Liu Pdf
"Offers a comprehensive, unified presentation of statistical designs and methods of analysis for all stages of pharmaceutical development--emphasizing biopharmaceutical applications and demonstrating statistical techniques with real-world examples."
Statistical Methods for Pharmaceutical Research Planning by S. W. Bergman Pdf
This book focuses on statistical methods which impinge more or less directly on the decisions that are made during the course of pharmaceutical and agro-chemical research, considering the four decision-making areas.
Planning Pharmaceutical Clinical Trials by William M. Wooding Pdf
Imparts a working understanding of the statistical principles and procedures essential to conducting successful clinical studies. Features a detailed catalog of experimental designs most commonly used in clinical work. Includes two chapters on elementary applied statistics and one on sample size estimation (the number of patients required).
Basic Statistics and Pharmaceutical Statistical Applications, Third Edition by James E. De Muth Pdf
Building on its best-selling predecessors, Basic Statistics and Pharmaceutical Statistical Applications, Third Edition covers statistical topics most relevant to those in the pharmaceutical industry and pharmacy practice. It focuses on the fundamentals required to understand descriptive and inferential statistics for problem solving. Incorporating new material in virtually every chapter, this third edition now provides information on software applications to assist with evaluating data. New to the Third Edition Use of Excel® and Minitab® for performing statistical analysis Discussions of nonprobability sampling procedures, determining if data is normally distributed, evaluation of covariances, and testing for precision equivalence Expanded sections on regression analysis, chi square tests, tests for trends with ordinal data, and tests related to survival statistics Additional nonparametric procedures, including the one-sided sign test, Wilcoxon signed-ranks test, and Mood’s median test With the help of flow charts and tables, the author dispels some of the anxiety associated with using basic statistical tests in the pharmacy profession and helps readers correctly interpret their results using statistical software. Through the text’s worked-out examples, readers better understand how the mathematics works, the logic behind many of the equations, and the tests’ outcomes.
Research Methods for Pharmaceutical Practice and Policy by Rajender R. Aparasu Pdf
This text provides the theory and practice for conducting pharmaceutical policy research. It covers all aspects of scientific research from conceptualising to statistical analysis. It also provides scientific basis and a good understanding of the principles and practice of conducting pharmaceutical policy research.
A Practical Approach to Using Statistics in Health Research by Adam Mackridge,Philip Rowe Pdf
A hands-on guide to using statistics in health research, from planning, through analysis, and on to reporting A Practical Approach to Using Statistics in Health Research offers an easy to use, step-by-step guide for using statistics in health research. The authors use their experience of statistics and health research to explain how statistics fit in to all stages of the research process. They explain how to determine necessary sample sizes, interpret whether there are statistically significant difference in outcomes between groups, and use measured effect sizes to decide whether any changes are large enough to be relevant to professional practice. The text walks you through how to identify the main outcome measure for your study and the factor which you think may influence that outcome and then determine what type of data will be used to record both of these. It then describes how this information is used to select the most appropriate methods to report and analyze your data. A step-by-step guide on how to use a range of common statistical procedures are then presented in separate chapters. To help you make sure that you are using statistics robustly, the authors also explore topics such as multiple testing and how to check whether measured data follows a normal distribution. Videos showing how to use computer packages to carry out all the various methods mentioned in the book are available on our companion web site. This book: • Covers statistical aspects of all the stages of health research from planning to final reporting • Explains how to report statistical planning, how analyses were performed, and the results and conclusion • Puts the spotlight on consideration of clinical significance and not just statistical significance • Explains the importance of reporting 95% confidence intervals for effect size • Includes a systematic guide for selection of statistical tests and uses example data sets and videos to help you understand exactly how to use statistics Written as an introductory guide to statistics for healthcare professionals, students and lecturers in the fields of pharmacy, nursing, medicine, dentistry, physiotherapy, and occupational therapy, A Practical Approach to Using Statistics in Health Research:From Planning to Reporting is a handy reference that focuses on the application of statistical methods within the health research context.
Statistical Issues in Drug Development by Stephen S. Senn Pdf
Drug development is the process of finding and producingtherapeutically useful pharmaceuticals, turning them into safe andeffective medicine, and producing reliable information regardingthe appropriate dosage and dosing intervals. With regulatoryauthorities demanding increasingly higher standards in suchdevelopments, statistics has become an intrinsic and criticalelement in the design and conduct of drug development programmes. Statistical Issues in Drug Development presents anessential and thought provoking guide to the statistical issues andcontroversies involved in drug development. This highly readable second edition has been updated toinclude: Comprehensive coverage of the design and interpretation ofclinical trials. Expanded sections on missing data, equivalence, meta-analysisand dose finding. An examination of both Bayesian and frequentist methods. A new chapter on pharmacogenomics and expanded coverage ofpharmaco-epidemiology and pharmaco-economics. Coverage of the ICH guidelines, in particular ICH E9,Statistical Principles for Clinical Trials. It is hoped that the book will stimulate dialogue betweenstatisticians and life scientists working within the pharmaceuticalindustry. The accessible and wide-ranging coverage make itessential reading for both statisticians and non-statisticiansworking in the pharmaceutical industry, regulatory bodies andmedical research institutes. There is also much to benefitundergraduate and postgraduate students whose courses include amedical statistics component.
Quantitative Methods in Pharmaceutical Research and Development by Olga V. Marchenko,Natallia V. Katenka Pdf
This contributed volume presents an overview of concepts, methods, and applications used in several quantitative areas of drug research, development, and marketing. Chapters bring together the theories and applications of various disciplines, allowing readers to learn more about quantitative fields, and to better recognize the differences between them. Because it provides a thorough overview, this will serve as a self-contained resource for readers interested in the pharmaceutical industry, and the quantitative methods that serve as its foundation. Specific disciplines covered include: Biostatistics Pharmacometrics Genomics Bioinformatics Pharmacoepidemiology Commercial analytics Operational analytics Quantitative Methods in Pharmaceutical Research and Development is ideal for undergraduate students interested in learning about real-world applications of quantitative methods, and the potential career options open to them. It will also be of interest to experts working in these areas.
Innovative Strategies, Statistical Solutions and Simulations for Modern Clinical Trials by Mark Chang,John Balser,Jim Roach,Robin Bliss Pdf
"This is truly an outstanding book. [It] brings together all of the latest research in clinical trials methodology and how it can be applied to drug development.... Chang et al provide applications to industry-supported trials. This will allow statisticians in the industry community to take these methods seriously." Jay Herson, Johns Hopkins University The pharmaceutical industry's approach to drug discovery and development has rapidly transformed in the last decade from the more traditional Research and Development (R & D) approach to a more innovative approach in which strategies are employed to compress and optimize the clinical development plan and associated timelines. However, these strategies are generally being considered on an individual trial basis and not as part of a fully integrated overall development program. Such optimization at the trial level is somewhat near-sighted and does not ensure cost, time, or development efficiency of the overall program. This book seeks to address this imbalance by establishing a statistical framework for overall/global clinical development optimization and providing tactics and techniques to support such optimization, including clinical trial simulations. Provides a statistical framework for achieve global optimization in each phase of the drug development process. Describes specific techniques to support optimization including adaptive designs, precision medicine, survival-endpoints, dose finding and multiple testing. Gives practical approaches to handling missing data in clinical trials using SAS. Looks at key controversial issues from both a clinical and statistical perspective. Presents a generous number of case studies from multiple therapeutic areas that help motivate and illustrate the statistical methods introduced in the book. Puts great emphasis on software implementation of the statistical methods with multiple examples of software code (both SAS and R). It is important for statisticians to possess a deep knowledge of the drug development process beyond statistical considerations. For these reasons, this book incorporates both statistical and "clinical/medical" perspectives.
Statistical Methodology in the Pharmaceutical Sciences by Donald A. Berry Pdf
A state-of-the-art handbook of statistical analysis for use in the pharmaceutical industry. Areas covered in this reference/text include: bioavailability, repeated-measures designs, dose-response, population models, multicenter trials, handling dropouts, survival analysis, robust data analysis, cate
Hybrid Frequentist/Bayesian Power and Bayesian Power in Planning Clinical Trials by Andrew P. Grieve Pdf
Hybrid Frequentist/Bayesian Power and Bayesian Power in Planning Clinical Trials provides a practical introduction to unconditional approaches to planning randomised clinical trials, particularly aimed at drug development in the pharmaceutical industry. This book is aimed at providing guidance to practitioners in using average power, assurance and related concepts. This book brings together recent research and sets them in a consistent framework and provides a fresh insight into how such methods can be used. Features: A focus on normal theory linking average power, expected power, predictive power, assurance, conditional Bayesian power and Bayesian power. Extensions of the concepts to binomial, and time-to-event outcomes and non-inferiority trials An investigation into the upper bound on average power, assurance and Bayesian power based on the prior probability of a positive treatment effect Application of assurance to a series of trials in a development program and an introduction of the assurance of an individual trial conditional on the positive outcome of an earlier trial in the program, or to the successful outcome of an interim analysis Prior distribution of power and sample size Extension of the basic approach to proof-of-concept trials with dual success criteria Investigation of the connection between conditional and predictive power at an interim analysis and power and assurance Introduction of the idea of surety in sample sizing of clinical trials based on the width of the confidence intervals for the treatment effect, and an unconditional version.
