Dose Finding and Beyond in Biopharmaceutical Development
Gebundenes Buch

Dose Finding and Beyond in Biopharmaceutical Development

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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 clinical trials then lower test doses to the minimal efficacious dose (MinED). Dose range of a study drug can be though...