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.ย
This highly readable second edition has been updated to include:
- Comprehensive coverage of the design and interpretation of clinical trials.
- Expanded sections on missing data, equivalence, meta-analysis and dose finding.
- An examination of both Bayesian and frequentist methods.
- A new chapter on pharmacogenomics and expanded coverage of pharmaco-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 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.Content:
Chapter 1 Introduction (pages 1โ7):
Chapter 2 A Brief and Superficial History of Statistics for Drug Developers (pages 9โ25):
Chapter 3 Design and Interpretation of Clinical Trials as Seen by a Statistician (pages 27โ42):
Chapter 4 Probability, Bayes, P?Values, Tests of Hypotheses and Confidence Intervals (pages 43โ53):
Chapter 5 The Work of the Pharmaceutical Statistician (pages 55โ66):
Chapter 6 Allocating Treatments to Patients in Clinical Trials (pages 67โ93):
Chapter 7 Baselines and Covariate Information (pages 95โ112):
Chapter 8 The Measurement of Treatment Effects (pages 113โ131):
Chapter 9 Demographic Subgroups: Representation and Analysis (pages 133โ148):
Chapter 10 Multiplicity (pages 149โ164):
Chapter 11 Intention to Treat, Missing Data and Related Matters (pages 165โ181):
Chapter 12 One?Sided and Two?Sided Tests and other Issues to Do with Significance and P?Values (pages 183โ193):
Chapter 13 Determining the Sample Size (pages 195โ212):
Chapter 14 Multicentre Trials (pages 213โ233):
Chapter 15 Active Control Equivalence Studies (pages 235โ250):
Chapter 16 Meta?Analysis (pages 251โ272):
Chapter 17 Cross?over Trials (pages 273โ285):
Chapter 18 n?of?1 Trials (pages 287โ294):
Chapter 19 Sequential Trials (pages 295โ315):
Chapter 20 Dose?Finding (pages 317โ336):
Chapter 21 Concerning Pharmacokinetics and Pharmacodynamics (pages 337โ360):
Chapter 22 Bioequivalence Studies (pages 361โ381):
Chapter 23 Safety Data, Harms, Drug Monitoring and Pharmaco?Epidemiology (pages 383โ404):
Chapter 24 Pharmaco?Economics and Portfolio Management (pages 405โ431):
Chapter 25 Concerning Pharmacogenetics, Pharmacogenomics and Related Matters (pages 433โ452):