ABSTRACT
The development of a new drug is a long, complex, and costly process. Cur-rent estimates show that it can take up to 14.7 years [1] and cost in excess of $800 million [2]. This complexity is a result of the large number of studies that need to be performed prior to the submission of a marketing application. Additionally, the complexity comes in part from the large number of regula-tions that govern the preclinical and clinical studies that support a New Drug Application (NDA). The U.S. compliance regulations that govern the pre-clinical and clinical studies that make up an NDA include Good Laboratory Practices (GLPs), Good Manufacturing Practices (GMPs), and Good Clinical Practices (GCPs). These regulations were written in the late 1970s and early 1980s to specify how preclinical safety studies, clinical trials, and development operations were to be conducted in support of an NDA.
