New drug development
Subtitle: design, methodology, and analysis
By: J. Rick Turner.
Publisher: J. Wiley & Sons
Published: 2007
Place of publication: Hoboken, N.J
Language: eng
ISBN-13: 9780470073735
Subjects: Drug development; Pharmacy; Clinical Trials; Pharmaceutical Preparations -- chemical synthesis; Drug Industry -- methods; Statistics
Notes: Includes bibliographical references and index.
Table of contents: title: New drug development; title: The regulatory environment for new drug development; title: Drug discovery; title: Nonclinical research; title: Design and methodology in clinical trials; title: Statistical analysis; title: Statistical significance : employment of hypothesis testing; title: Clinical significance : employment of confidence intervals; title: Sample-size estimation; title: Safety assessment in clinical trials; title: Efficacy assessment in clinical trials; title: Pharmaceutical and biopharmaceutical drug manufacturing; title: Post-marketing surveillance and evidence-based medicine; title: Unifying themes and concluding comments.