'Offers a comprehensive, unified presentation of statistical designs and methods of analysis for ...

Praise for the Second Edition:'... this is a useful, comprehensive compendium of almost every pos...

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

Preeminent Experts Update a Well-Respected BookTaking into account the regulatory and scientific ...

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...

Methodologies for Biosimilar Product Development covers the practical and challenging issues that...

In the United States, a rare disease is defined by the Orphan Drug Act as a disorder or condition...

Methodologies for Biosimilar Product Development covers the practical and challenging issues that...

This second edition reflects recent developments and regulatory positions on the use of adaptive ...

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

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