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.


Statistical Methods for Pharmaceutical Research Planning

Statistical Methods for Pharmaceutical Research Planning

Author: S. W. Bergman

Publisher: CRC Press

Published: 2020-10-28

Total Pages: 270

ISBN-13: 1000105520

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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

Statistical Methodology in the Pharmaceutical Sciences

Author: D. A. Berry

Publisher: CRC Press

Published: 2016-04-19

Total Pages: 592

ISBN-13: 1482276860

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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


Pharmaceutical Statistics Using SAS

Pharmaceutical Statistics Using SAS

Author: Alex Dmitrienko, Ph.D.

Publisher: SAS Institute

Published: 2007-02-07

Total Pages: 464

ISBN-13: 1629590304

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Introduces a range of data analysis problems encountered in drug development and illustrates them using case studies from actual pre-clinical experiments and clinical studies. Includes a discussion of methodological issues, practical advice from subject matter experts, and review of relevant regulatory guidelines.


Pharmaceutical Research Methodology & Bio-Statistics

Pharmaceutical Research Methodology & Bio-Statistics

Author: Subba Bayya Rao

Publisher: Pharmamed Press

Published: 2023-05

Total Pages: 0

ISBN-13: 9789395039345

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"Pharmaceutical Research Methodology and Bio-Statistics: Theory and Practice" is aimed in understanding the fundamental concepts of developing a research bent of mind by careful planning, execution, collection of data and analyzing for statistical significance. The book is aimed at B. Pharm, Pharm D, Pharm D (PB), M. Pharm, allied course students, researchers at the academic and industry levels, Ph. D scholars, policy makers, regulators etc. Key Features: - Distinguishing statistics and bio-statistics - How to identify a problem, plan for research and execute the idea - Chemical abstract literature search - Anatomy of a research paper - Compare and contrast of research proposal, research report, research paper, patent document, synopsis - Concept of meta-analysis to resolve research ambiguities - Data collection, cleansing, presenting - How to overcome missing data - Introduction to Probability, Permutations and Combinations - Parametric distributions - binomial, poisson, normal, chi-square, student 't', F distributions - Extra information on Bernoulli Distribution and Chebyshev's Theorem - Role of Type I and Type II errors, Power, sample size, confidence level, confidence interval, confidence limits - How to judge whether data upon analysis is statistical significant or not - Developing hypothesis as null, alternate and how to draw conclusion after conducting suitable statistical test - Non-parametric statistical test - Run, Sign, Wilcoxon Signed rank, Wilcoxon rank sum tests - Parametric, Non-parametric ANOVAs (1-way with multiple comparisons, 2-way, cross over, 3-way) - Step wise Parametric and non-parametric problem solving - Applications of linear regression and correlation coef ficient relating to pharmaceuticals - Appended with Multi-linear Regression Analysis (Mathematical and Excel Calculation)


Multiple Testing Problems in Pharmaceutical Statistics

Multiple Testing Problems in Pharmaceutical Statistics

Author: Alex Dmitrienko

Publisher: CRC Press

Published: 2009-12-08

Total Pages: 323

ISBN-13: 1584889853

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Useful Statistical Approaches for Addressing Multiplicity IssuesIncludes practical examples from recent trials Bringing together leading statisticians, scientists, and clinicians from the pharmaceutical industry, academia, and regulatory agencies, Multiple Testing Problems in Pharmaceutical Statistics explores the rapidly growing area of multiple c


Quantitative Methods in Pharmaceutical Research and Development

Quantitative Methods in Pharmaceutical Research and Development

Author: Olga V. Marchenko

Publisher: Springer Nature

Published: 2020-09-24

Total Pages: 445

ISBN-13: 3030485552

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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.


Essential Statistics for the Pharmaceutical Sciences

Essential Statistics for the Pharmaceutical Sciences

Author: Philip Rowe

Publisher: John Wiley & Sons

Published: 2015-07-20

Total Pages: 431

ISBN-13: 1118913418

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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.


Bayesian Methods in Pharmaceutical Research

Bayesian Methods in Pharmaceutical Research

Author: Emmanuel Lesaffre

Publisher: CRC Press

Published: 2020-04-15

Total Pages: 547

ISBN-13: 1351718673

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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.