
115Chapter ve: The fundamental solution for reliability assurance:
expense risk due to side effects and so on. Let’s also identify issues related
to clinical experiments and consider their correctives.
Since the side effects of medicines can be regarded as problems, the
side effect rate is equivalent to the concept of the failure rate. If a new
medicine evidences no problems in a series of clinical trials, as shown in
Table5.5, its effectiveness can be accepted. However, since phase 3 in the
clinical trials has the same test period (3 years) as phase 2, saying that it
conrms long-term safety would be incorrect. For a medicine that “passes” ...