Księgarnia naukowa
English Polski
Dostęp on-line

Książki

0.00 PLN
Schowek (0) 
Schowek jest pusty
Wydawcy udostępniają darmowe zasoby na czas epidemii


Statistical Thinking for Non-Statisticians in Drug Regulation

Statistical Thinking for Non-Statisticians in Drug Regulation

Autorzy
Wydawnictwo John Wiley & Sons
Data wydania 01/10/2014
Wydanie Drugie
Liczba stron 368
Forma publikacji książka w twardej oprawie
Poziom zaawansowania Dla profesjonalistów, specjalistów i badaczy naukowych
Język angielski
ISBN 9781118470947
Kategorie Badania kliniczne, Prawdopodobieństwo i statystyka, Technologia farmaceutyczna
360.50 PLN (z VAT)
$96.62 / €79.56 / £70.35 /
Produkt na zamówienie
Dostawa 3-4 tygodnie
Ilość
Do schowka

Opis książki

Statistical Thinking for Non-Statisticians in Drug Regulation, Second Edition, is a need-to-know guide to understanding statistical methodology, statistical data and results within drug development and clinical trials. It provides non-statisticians working in the pharmaceutical and medical device industries with an accessible introduction to the knowledge they need when working with statistical information and communicating with statisticians. It covers the statistical aspects of design, conduct, analysis and presentation of data from clinical trials in drug regulation and improves the ability to read, understand and critically appraise statistical methodology in papers and reports. As such, it is directly concerned with the day-to-day practice and the regulatory requirements of drug development and clinical trials. Fully conversant with current regulatory requirements, this second edition includes five new chapters covering Bayesian statistics, adaptive designs, observational studies, methods for safety analysis and monitoring and statistics for diagnosis. Authored by a respected lecturer and consultant to the pharmaceutical industry, Statistical Thinking for Non-Statisticians in Drug Regulation is an ideal guide for physicians, clinical research scientists, managers and associates, data managers, medical writers, regulatory personnel and for all non-statisticians working and learning within the pharmaceutical industry.

Statistical Thinking for Non-Statisticians in Drug Regulation

Spis treści

Preface to the second edition xv Preface to the first edition xvii Abbreviations xxi 1 Basic ideas in clinical trial design 1 1.1 Historical perspective 1 1.2 Control groups 2 1.3 Placebos and blinding 3 1.4 Randomisation 3 1.5 Bias and precision 9 1.6 Between- and within-patient designs 11 1.7 Crossover trials 12 1.8 Signal noise and evidence 13 1.9 Confirmatory and exploratory trials 15 1.10 Superiority equivalence and non-inferiority trials 16 1.11 Data and endpoint types 17 1.12 Choice of endpoint 18 2 Sampling and inferential statistics 23 2.1 Sample and population 23 2.2 Sample statistics and population parameters 24 2.3 The normal distribution 28 2.4 Sampling and the standard error of the mean 31 2.5 Standard errors more generally 34 3 Confidence intervals and p-values 38 3.1 Confidence intervals for a single mean 38 3.2 Confidence interval for other parameters 42 3.3 Hypothesis testing 45 4 Tests for simple treatment comparisons 56 4.1 The unpaired t-test 56 4.2 The paired t-test 57 4.3 Interpreting the t-tests 60 4.4 The chi-square test for binary data 61 4.5 Measures of treatment benefit 64 4.6 Fisher s exact test 69 4.7 Tests for categorical and ordinal data 71 4.8 Extensions for multiple treatment groups 75 5 Adjusting the analysis 78 5.1 Objectives for adjusted analysis 78 5.2 Comparing treatments for continuous data 78 5.3 Least squares means 82 5.4 Evaluating the homogeneity of the treatment effect 83 5.5 Methods for binary categorical and ordinal data 86 5.6 Multi-centre trials 87 6 Regression and analysis of covariance 89 6.1 Adjusting for baseline factors 89 6.2 Simple linear regression 89 6.3 Multiple regression 91 6.4 Logistic regression 94 6.5 Analysis of covariance for continuous data 94 6.6 Binary categorical and ordinal data 101 6.7 Regulatory aspects of the use of covariates 103 6.8 Baseline testing 105 7 Intention-to-treat and analysis sets 107 7.1 The principle of intention-to-treat 107 7.2 The practice of intention-to-treat 110 7.3 Missing data 113 7.4 Intention-to-treat and time-to-event data 118 7.5 General questions and considerations 120 8 Power and sample size 123 8.1 Type I and type II errors 123 8.2 Power 124 8.3 Calculating sample size 127 8.4 Impact of changing the parameters 130 8.5 Regulatory aspects 132 8.6 Reporting the samp

Polecamy również książki

Strony www Białystok Warszawa
801 777 223