Details

Subject(s)

• Drug development [Browse]
• Pharmacy [Browse]

Series

Statistics in practice. [More in this series]

Summary note

"From the initial stages of identifying a potential drug candidate to receiving FDA approval, New Drug Development focuses on the collection, analysis, and interpretation of numerical representations of information throughout the drug development process. This timely text provides a self-contained overview of the new drug development process, while also emphasizing the importance of ethical, biological, social, and political considerations."--BOOK JACKET.

Bibliographic references

Includes bibliographical references (p. [245]-257) and index.

Contents

• Ch. 1. New drug development
• Ch. 2. The regulatory environment for new drug development
• Ch. 3. Drug discovery
• Ch. 4. Nonclinical research
• Ch. 5. Design and methodology in clinical trials
• Ch. 6. Statistical analysis
• Ch. 7. Statistical significance : employment of hypothesis testing
• Ch. 8. Clinical significance : employment of confidence intervals
• Ch. 9. Sample-size estimation
• Ch. 10. Safety assessment in clinical trials
• Ch. 11. Efficacy assessment in clinical trials
• Ch. 12. Pharmaceutical and biopharmaceutical drug manufacturing
• Ch. 13. Postmarketing surveillance and evidence-based medicine
• Ch. 14. Unifying themes and concluding comments
• App. Additional resources for training executives and professors.

Show 12 more Contents items

ISBN

• 9780470073735 (cloth : alk. paper)
• 047007373X (cloth : alk. paper)

LCCN

2007008032

OCLC

85498627

RCP

C - S

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