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

This book provides a broad perspective of new quantitative methods in HIV AIDS research, contribu...

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

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

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

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

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

Taking into account the International Conference Harmonisation E5 framework for bridging studies,...

Illustrating how stability studies play an important role in drug safety and quality assurance, t...

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

Innovative Methods for Rare Diseases Drug Development focuses on biostatistical applications in t...

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

Written by a top biostatistics researcher, this is the first book entirely devoted to the statist...

This acclaimed book covers the principles and methodologies in adaptive design and analysis that ...

Written by a top biostatistics researcher, this is the first book entirely devoted to the statist...

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 ...

The US Food and Drug Administration's Report to the Nation in 2004 and 2005 indicated that one of...

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

Translational medicine has become increasingly important in pharmaceutical research development. ...

Praise for the Second Edition: '...a grand feast for biostatisticians. It stands ready to satisfy...

Taking into account the International Conference Harmonisation E5 framework for bridging studies,...