Chapter 13. Doxil® – the First FDA-approved Nano-drug: from Basics via CMC, Cell Culture and Animal Studies to Clinical Use

Doxil® was the first nano-drug to be approved by the US Food and Drug Administration and was developed through 7.5 years of major efforts in research, R&D, and development work as well as clinical studies by many people located in Jerusalem, in California, and in many hospitals worldwide that were involved in the various stages of Doxil® clinical trials. Hadassah University Hospital was the site of the first Doxil® clinical trial. The history of Doxil® development is reviewed and the author describes in short the scientific highlights of the development of Doxil® and the lessons learned from its 20 years of use, concentrating on the importance and relevance of cell culture studies. This chapter also discusses in short some of the new surprising findings from work on Doxil®, which have not yet been published.