New drug development
The regulatory environment for new drug development
Drug discovery
Nonclinical research
Design and methodology in clinical trials
Statistical analysis
Statistical significance : employment of hypothesis testing
Clinical significance : employment of confidence intervals
Sample-size estimation
Safety assessment in clinical trials
Efficacy assessment in clinical trials
Pharmaceutical and biopharmaceutical drug manufacturing
Postmarketing surveillance and evidence-based medicine
Unifying themes and concluding comments.
OBNB doesn't sell books, but you may be able to find a copy at one of these websites:
New drug development : design, methodology, and analysis by J. Rick Turner. ISBN 9780470073735. Published by Wiley in 2007. Publication and catalogue information, links to buy online and reader comments.
