New drug development : design, methodology, and analysis / J. Rick Turner.

Hoboken, N.J. : Wiley-Interscience, [2007], ©2007.

xxi, 270 pages : illustrations ; 25 cm.

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

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.