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Author: S. W. Bergman
Publisher: CRC Press
Published: 2020-10-28
Total Pages: 270
ISBN-13: 1000105520
DOWNLOAD EBOOKThis 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.
Author: S. W. Bergman
Publisher: CRC Press
Published: 2020-10-29
Total Pages: 273
ISBN-13: 1000148734
DOWNLOAD EBOOKThis 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.
Author: Institute of Medicine
Publisher: National Academies Press
Published: 2001-01-01
Total Pages: 221
ISBN-13: 0309171148
DOWNLOAD EBOOKClinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.
Author: Frederick W. Faltin
Publisher: John Wiley & Sons
Published: 2012-07-24
Total Pages: 533
ISBN-13: 1119942047
DOWNLOAD EBOOKStatistical Methods in Healthcare In recent years the number of innovative medicinal products and devices submitted and approved by regulatory bodies has declined dramatically. The medical product development process is no longer able to keep pace with increasing technologies, science and innovations and the goal is to develop new scientific and technical tools and to make product development processes more efficient and effective. Statistical Methods in Healthcare focuses on the application of statistical methodologies to evaluate promising alternatives and to optimize the performance and demonstrate the effectiveness of those that warrant pursuit is critical to success. Statistical methods used in planning, delivering and monitoring health care, as well as selected statistical aspects of the development and/or production of pharmaceuticals and medical devices are also addressed. With a focus on finding solutions to these challenges, this book: Provides a comprehensive, in-depth treatment of statistical methods in healthcare, along with a reference source for practitioners and specialists in health care and drug development. Offers a broad coverage of standards and established methods through leading edge techniques. Uses an integrated case study based approach, with focus on applications. Looks at the use of analytical and monitoring schemes to evaluate therapeutic performance. Features the application of modern quality management systems to clinical practice, and to pharmaceutical development and production processes. Addresses the use of modern statistical methods such as Adaptive Design, Seamless Design, Data Mining, Bayesian networks and Bootstrapping that can be applied to support the challenging new vision. Practitioners in healthcare-related professions, ranging from clinical trials to care delivery to medical device design, as well as statistical researchers in the field, will benefit from this book.
Author: Philip Rowe
Publisher: John Wiley & Sons
Published: 2015-07-20
Total Pages: 431
ISBN-13: 1118913418
DOWNLOAD EBOOKEssential 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: Subba Bayya Rao
Publisher: Pharmamed Press
Published: 2023-05
Total Pages: 0
ISBN-13: 9789395039345
DOWNLOAD EBOOK"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)
Author: Stephen S. Senn
Publisher: John Wiley & Sons
Published: 2008-02-28
Total Pages: 523
ISBN-13: 9780470723579
DOWNLOAD EBOOKDrug 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.
Author: Robert H. Riffenburgh
Publisher: Academic Press
Published: 2006
Total Pages: 680
ISBN-13:
DOWNLOAD EBOOKMedicine deals with treatments that work often but not always, so treatment success must be based on probability. Statistical methods lift medical research from the anecdotal to measured levels of probability. This book presents the common statistical methods used in 90% of medical research, along with the underlying basics, in two parts: a textbook section for use by students in health care training programs, e.g., medical schools or residency training, and a reference section for use by practicing clinicians in reading medical literature and performing their own research. The book does not require a significant level of mathematical knowledge and couches the methods in multiple examples drawn from clinical medicine, giving it applicable context. Easy-to-follow format incorporates medical examples, step-by-step methods, and check yourself exercises Two-part design features course material and a professional reference section Chapter summaries provide a review of formulas, method algorithms, and check lists Companion site links to statistical databases that can be downloaded and used to perform the exercises from the book and practice statistical methods New in this Edition: New chapters on: multifactor tests on means of continuous data, equivalence testing, and advanced methods New topics include: trial randomization, treatment ethics in medical research, imputation of missing data, and making evidence-based medical decisions Updated database coverage and additional exercises Expanded coverage of numbers needed to treat and to benefit, and regression analysis including stepwise regression and Cox regression Thorough discussion on required sample size
Author: Hisashi Tanizaki
Publisher: CRC Press
Published: 2004-01-21
Total Pages: 538
ISBN-13: 9780203022023
DOWNLOAD EBOOKReflecting current technological capacities and analytical trends, Computational Methods in Statistics and Econometrics showcases Monte Carlo and nonparametric statistical methods for models, simulations, analyses, and interpretations of statistical and econometric data. The author explores applications of Monte Carlo methods in Bayesian estimation, state space modeling, and bias correction of ordinary least squares in autoregressive models. The book offers straightforward explanations of mathematical concepts, hundreds of figures and tables, and a range of empirical examples. A CD-ROM packaged with the book contains all of the source codes used in the text.
Author: Karl E. Peace
Publisher: Routledge
Published: 2017-09-19
Total Pages: 390
ISBN-13: 1351414437
DOWNLOAD EBOOKThis book is a compilation of topics addressed by the ASA Biopharmaceutical Section work groups, including the etiology and evolution of the work groups, the work group guidelines and structure, and the statistical issues associated with clinical trials in clinical drug development programs.
