
Organizational Structure ◾ 147
pre-described process of pharmaceutical product testing. The process, as
described by FDA, consists of the following steps:
◾ Preclinical trials (involving laboratory animals)
◾ Phase I (involving a few healthy volunteers)
◾ Phase II (limited patients enrolled; compared to placebo)
◾ Phase III (larger patient population; compared to best available treatment)
Seek the truth. Costs increase exponentially at later stages. Be prepared
to accept failure. If failure appears likely, it is best to cut your losses early. If
your initial decision was based on the best available information available to
you at the time, n