'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...

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

This is the first book entirely devoted to the design and analysis of TCM development from a West...

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