New Drug Development : An Introduction to Clinical Trials: Second Edition - Turner, J. Rick.; SpringerLink (Online service) (New York, NY : Springer New York : Imprint: Springer, 2010)
New Drug Development -- The Regulatory Environment -- Drug Discovery -- Nonclinical Research -- Designing Clinical Trials -- Conducting Clinical Trials I: Experimental Methodology -- Conducting Clinical Trials II: Operational Execution -- Statistical Analysis -- Statistical Significance -- Clinical Significance -- Sample Size Estimation -- General Safety Assessments -- Efficacy Assessment -- Cardiac and Cardiovascular Safety Assessments -- Manufacturing Small Molecule Drugs and Biologicals -- Postmarketing Surveillance -- Main Themes and Concluding Comments.
Keywords: Pharmaceutical technology; Pharmaceutical Sciences/Technology.