ABSTRACT
Discovery and development of safe and effective new medicines is a long, difcult, and expensive process. A new molecular entity (NME), sometimes also called a new chemical entity (NCE), is characterized for its potential therapeutic applications and toxicological prole in nonprimate species, which is followed by extensive animal and human testing. On average, it costs a company >$800 million and 10-15 years to get one drug from the laboratory to patients. Only 5 in 5000 compounds that enter preclinical testing make it to human testing. Only one of those ve drugs entering human clinical trials is approved for commercialization.
