Description
Book SynopsisA self-contained introduction to Statistics, presented in the context of clinical trials and pharmaceutical drug development. This title focuses on the statistical analyses most commonly used in drug development. It emphasises the importance of descriptive statistics as well as inferential statistics.
Trade Review'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 *
Table of ContentsSection 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.
