Section 1 Setting the Scene; Statistic, Statistics and Statistical Analyses; New Drug Development; Section 2 Design, Analysis and Interpretation; Data, Central Tendency and Variation; Research Questions and Research Hypotheses; Study Design and Methodology; Hypothesis Testing and Estimation; Section 3 Pre-clinical Drug Development; Overview of Pre-clinical Drug Development; Pharmacokinetic Studies; Pharmacodynamic Studies; Section 4 Clinical Drug Development; Phase 1: Clinical Trials; Confirmatory Clinical Trials: Safety Data; Confirmatory Clinical Trials: Efficacy Data; Health Outcomes Data; Section 5 Additional Pharmaceutical Statistical Techniques; Analysis of Frequencies; Analysis of Association and Prediction; Analysis of Ranked Outcomes; Section 6 Writing Regulatory Documents and Scientific Manuscripts; Scientific Communication: Goals and Necessary Statistical Skills.
'It fills the gap that exists between books that focus on research
design and those that address statistical methods. The authors have
clearly met this worthy objective. This book fills a unique
position and uses innovative method.'
Michael R Jacobs, BS, PharmD (Temple University of Pharmacy) Doody Enterprises July 2008 -- Michael R Jacobs * Doody's Notes *