ABSTRACT
The process by which a new therapeutic entity is discovered and developed
to the point that it is available to patients in the marketplace is complex,
expensive and long. I will not pretend to present or analyze this process in any
detail here, but rather to give a basic understanding of the process and of the
components which may be outsourced to a contract organization. There are
no current or comprehensive volumes describing this process, though there
are some volumes on the area (Sneader, 1986; Guarino, 1987; Smith, 1992;
Spilker, 1994; Mathieu, 2000).
