Stephen S. Senn Ordre des livres (chronologique)

Drug development involves discovering and producing therapeutically useful pharmaceuticals, ensuring their safety and efficacy, and providing reliable dosing information. As regulatory authorities impose higher standards, statistics has become a vital component in designing and conducting drug development programs. This guide addresses the statistical issues and controversies in drug development, offering an updated second edition that includes comprehensive coverage of clinical trial design and interpretation. It expands on topics such as missing data, equivalence, meta-analysis, and dose finding, while examining both Bayesian and frequentist methods. A new chapter on pharmacogenomics and enhanced sections on pharmaco-epidemiology and pharmaco-economics are also included, along with a focus on ICH guidelines, particularly ICH E9, which outlines statistical principles for clinical trials. The book aims to foster dialogue between statisticians and life scientists in the pharmaceutical industry. Its accessible and extensive coverage makes it essential for statisticians and non-statisticians in the pharmaceutical sector, regulatory bodies, and medical research institutes. Additionally, it offers valuable insights for undergraduate and postgraduate students studying medical statistics.