ABSTRACT
The reader will notice, especially during the latter part of the chapter where individual guidances and guidelines are discussed, that there is quite a bit of overlap between the U.S. and the ICH documents as well as within the ICH documents. However, in the view of the authors, removing or minimizing this overlap would be a disservice to these documents and so even at the risk of being repetitious, regulatory basis which support
clinical pharmacology and biopharmaceutic information from all the relevant documents is presented.
