New drug development : design, methodology, and analysis

✍ Scribed by J Rick Turner

• Publisher: Wiley-Interscience
• Year: 2007
• Tongue: English
• Leaves: 297
• Series: Statistics in practice
• Category: Library

✦ Synopsis

'New Drug Development' acquaints students and practitioners in the related fields of pharmaceutical sciences, clinical trials, and evidence-based medicine with the necessary study design concepts and statistical practices to allow them to understand how drug developers plan and evaluate their drug development.

✦ Table of Contents

Content: 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.
Abstract: 'New Drug Development' acquaints students and practitioners in the related fields of pharmaceutical sciences, clinical trials, and evidence-based medicine with the necessary study design concepts and statistical practices to allow them to understand how drug developers plan and evaluate their drug development