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Bibframe Work

Title
New drug development
Type
Text
Monograph
Subject
Drug development (LCSH)
Pharmacy (LCSH)
Clinical Trials (MESH)
Pharmaceutical Preparations--chemical synthesis (MESH)
Drug Industry--methods (MESH)
Statistics (MESH)
Language
English
Illustrative Content
Illustrations
Classification
LCC: RS189 .T85 2007
QV 771 T948n 2007
DDC: 615/.19 full
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Supplementary Content
bibliography
index
Content
text
Table Of Contents
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.
Authorized Access Point
Turner, J. Rick New drug development