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New Drug Development
Design, Methodology, and Analysis
by J. Rick Turnerl

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.

New Drug Development provides an indispensable overview of an otherwise confusing and fragmented set of topics.

Contents

  1. New Drug Development
  2. The Regulatory Environment for New Drug Development

Drug Discovery and Nonclinical Research

  1. Drug Discovery
  2. Nonclinical Research

Design, Methodology, and Analysis

  1. Design and Methodology in Clinical Trials
  2. Statistical Analysis
  3. Statistical Significance: Employment of Hypothesis testing
  4. Clinical Significance: Employment of Confidence Intervals
  5. Sample-Size Estimation

Lifecycle Clinical Development

  1. Safety Assessment in Clinical Trials
  2. Efficacy Assessment in Clinical Trials
  3. Pharmaceutical and Biopharmaceutical Drug Manufacturing
  4. Postmarketing Surveillance and Evidence-Based Medicine

Intergrative Discussion

  1. Unifying Themes and Concluding Comments

Index

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New Drug Development
Design, Methodology, and Anaylsis
by J. Rick Turner

2007 270 pages $98.95 + shipping
Texas residents please add 6.75 % sales tax

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