When a biological drug patent expires, alternative biosimilar products are developed. The develop...

In clinical trial practice, controversial statistical issues inevitably occur regardless of the c...

This work details the statistical inference of linear models including parameter estimation, hypo...

Quantitative Methods in HIV AIDS Research provides a comprehensive discussion of modern statistic...

In response to the US FDA's Critical Path Initiative, innovative adaptive designs are being used ...

Advanced Statistics in Regulatory Critical Clinical Initiatives is focused on the critical clinic...

Emphasizing the role of good statistical practices (GSP) in drug research and formulation, this b...

Statistical methods that are commonly used in the review and approval process of regulatory submi...

With new statistical and scientific issues arising in adaptive clinical trial design, including t...

When a biological drug patent expires, alternative biosimilar products are developed. The develop...