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Dose Finding and Beyond in Biopharmaceutical Development

By Jingjing Ye (Editor), Ding-Geng Chen (Editor), Wen Zhou (Editor), Qiqi Deng (Editor), Joseph C. Cappelleri (Editor)
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$249.00
By Jingjing Ye (Editor), Ding-Geng Chen (Editor), Wen Zhou (Editor), Qiqi Deng (Editor), Joseph C. Cappelleri (Editor)
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This book covers topics in 2 parts: 1) Review of FDA Guidance, 2) Novel Designs and Analyses. While covering basic principles of dose finding, this book details advancements made in drug development.

Finding the right dose(s) is one of the most important objectives in new drug development. In Phase I clinical development, one of the objectives is to escalate test doses from low to high. The low doses should be safe, then escalate up to the maximally tolerable dose (MTD). Phase Ⅱ clinical tri...

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