Dose Finding in Drug Development

This book emphasizes dose selection issues from a statistical point of view. It presents statistical applications in the design and analysis of dose–response studies. The importance of this subject can be found from the International Conference on Harmonization (ICH) E4 Guidance document. Establishing the dose–response relationship is one of the most important act- ities in developing a new drug. A clinical development program for a new drug can be broadly divided into four phases – namely ...