Oregon Bioscience Online

Drug Development & Approval Process

The fully capitalized cost to develop a new drug, including studies conducted after receiving regulatory approval, averages $897 million, according to an analysis by the Tufts Center for the Study of Drug Development. The Tufts Center study was based on an analysis of data covering 68 drugs from 10 multinational, foreign- and U.S.-owned pharmaceutical firms during the 1990s.

Notably, only five in 5,000 compounds that enter preclinical testing make it to human testing, and only one of the five tested in people is approved by the Food & Drug Administration (FDA).

Clinical Trials
	Preclinical		Phase I	Phase II	Phase III		FDA		Phase IV
Years	6.5	-	1.5	2	3.5	-	1.5	15 total	-
Test Population	Laboratory & animal studies	-	20 to 80 healthy volunteers	100 to 300 patient volunteers	1,000 to 3,000 patient volunteers	-	-	-	-
Purpose	Assess safety & biological activity	File Investi- gational New Drug (IND) at FDA	Determine safety & dosage	Evaluate effectiveness, look for side efects	Confirm effectiveness, monitor adverse reactions from long-term use	File New Drug Appli- cation (NDA) at FDA	Review Process/ approval	-	Additional post- market testing
Success Rate	5,000 compounds evaluated	-	-	5 enter clinical trials	-	-	1 approved	-	-

Source: Tufts Center for the Study of Drug Development.