Statistical Issues in Drug Development
Drug development is the process of finding and producing therapeutically useful pharmaceuticals, turning them into safe and effective medicine, and producing reliable information regarding the appropriate dosage and dosing intervals. With regulatory authorities demanding increasingly higher standards in such developments, statistics has become an intrinsic and critical element in the design and conduct of drug development programmes.
Statistical Issues in Drug Development presents an essential and thought provoking guide to the statistical issues and controversies involved in drug development.
This highly readable second edition has been updated to include:
It is hoped that the book will stimulate dialogue between statisticians and life scientists working within the pharmaceutical industry. The accessible and wide-ranging coverage make it essential reading for both statisticians and non-statisticians working in the pharmaceutical industry, regulatory bodies and medical research institutes. There is also much to benefit undergraduate and postgraduate students whose courses include a medical statistics component.
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3 Design and Interpretation of Clinical Trials as Seen by a Statistician
4 Probability Bayes Pvalues Tests of Hypotheses and Confidence Intervals
5 The Work of the Pharmaceutical Statistician
Part 2 Statistical Issues Debatable and Controversial Topics in Drug Development
14 Multicentre Trials
15 Active Control Equivalence Studies
17 Crossover Trials
18 nof1 Trials
19 Sequential Trials
21 Concerning Pharmacokinetics and Pharmacodynamics
6 Allocating Treatments to Patients in Clinical Trials
7 Baselines and Covariate Information
8 The Measurement of Treatment Effects
9 Demographic Subgroups Representation and Analysis
11 Intention to Treat Missing Data and Related Matters
12 Onesided and Twosided Tests and other Issues to Do with Significance and Pvalues
13 Determining the Sample Size