(Download) Design and Analysis of Bridging Studies (Chapman & Hall/CRC Biostatistics Series)






 | #2766363 in Books |  2012-07-26 | Original language:English | PDF # 1 |  9.50 x6.50 x.75l,1.18 | File Name: 1439846340 | 287 pages


|| ||"… a place to start acquiring an understanding of bridging and multi-regional studies and as a supplement to ICH-E5 and local region’s current regulatory implementation guidance. … this book is also intended to stimulate additional resear

As the development of medicines has become more globalized, the geographic variations in the efficacy and safety of pharmaceutical products need to be addressed. To accelerate the product development process and shorten approval time, researchers are beginning to design multiregional trials that incorporate subjects from many countries around the world under the same protocol.

Design and Analysis of Bridging Studies addresses the issues arisin...


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