ABSTRACT
Clinical pharmacologists are often asked to conduct special studies on mechanism of action, drug-drug interactions, bioequivalence, disposition, and other such investigations, the nature of Phase I and II studies and special clinical pharmacology investigations determine the education, experience, and specific skills required by an industrial clinical pharmacology staff. Since clinical pharmacology studies are characteristically small in size and intensive in design, it is essential that statisticians participate in the planning as well as the analysis to ensure that appropriate measurements and numbers of subjects are employed to give meaningful results. To summarize the principal role of clinical pharmacology in the pharmaceutical industry is to conduct Phase I and II investigations which are adequate in design and execution to permit a decision on the future course of new drug candidates. Planning includes careful attention to animal pharmacology, toxicology, drug disposition information, as well as to experimental design to minimize the study population and avoid the need for repetition of studies.
