New drug development :design, methodology, and analysis
Hoboken, N.J.
Wiley-Interscience
2007
xxi, 270 p. : ill. ; 25 cm
Statistics in practice
Includes bibliographical references )p. ]245[-257( and index
J. Rick Turner
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