In recent years, the use of adaptive design methods in clinical research and development
based on accrued data has become very popular due to its flexibility and efficiency. Based on …

Praise for the Second Edition: "… this is a useful, comprehensive compendium of almost every
possible sample size formula. The strong organization and carefully defined formulae will …

Bioavailability is referred to as the extent and rate to which the active drug ingredient or active
moiety from the drug product is absorbed and becomes available at the site of drug action. …

In clinical research, in addition to continuous responses, primary clinical endpoints for
assessment of efficacy and safety of a drug product under investigation could be binary responses…

Praise for the First Edition of Design and Analysis of Clinical Trials" An excellent book, providing
a discussion of the clinical trial process from designing the study through analyzing the …

Although adaptive design methods are flexible and useful in clinical research, little or no
regulatory guidelines are available. One of the first books on the topic, Adaptive Design …

In the past decade, it has been recognized that increasing spending on biomedical
research has not resulted in an increase in the success rate of pharmaceutical and clinical …

"Provides a comprehensive summary of the continuously growing literature and research
activities on the regulatory requirements, scientific and practical issues, and statistical …

Biosimilars (or follow-on biologics) are a new class of medicine which enters the market
subsequent to a previously approved version. They have demonstrated similarity to innovator …

Background: Cytomegalovirus (CMV) is the most prevalent opportunistic infection after lung
transplantation. Current strategies do not prevent CMV in most at-risk patients. Objective: To …