Design and analysis of bridging studies

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Science (General)
Design and analysis of bridging studies

Design and analysis of bridging studies

Name: Design and analysis of bridging studies
ISBN: 9781439846353

Chin-Fu Hsiao, Jen-pei Liu, Shein-Chung Chow

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This book provides a comprehensive and unified summary of the growing literature and research activities on regulatory requirements, scientific and practical issues, and statistical methodology pertaining to the design and evaluation of bridging studies, which provide pharmacodynamic or clinical data that allow extrapolation of the foreign clinical data to a new region. Along with a thorough overview of bridging studies, the text addresses issues arising from bridging studies, including ethnic sensitivity, necessity of bridging studies, types of bridging studies, and assessment of similarity b.

Categorias:

Science (General)

Ano:

2013

Editora:

CRC Press

Idioma:

english

Páginas:

284

ISBN 10:

1439846359