Utilization of methods and models undoubtedly has its merits in the ev
aluation and interpretation of data in clinical pharmacology, but it i
s a process that ought to follow rigorous scientific rules and thought
s. For a discussion about optimization-a word concerning the quality o
f a procedure-the meaning and extent of the terms, methods, and models
ore defined. and different types of models are identified. In drug de
velopment. many steps can be improved, some within the pharmaceutical
companies, some in the interaction with other organizations. This situ
ation requires good organization and scientific sincerity. Some of the
pitfalls encountered in daily work are described.