ABSTRACT
In recent years, there has been an increased awareness and interest in personalized medicine. Since the efcacy of a therapeutic product is observed only in the respondents while the toxicity is universally shared by the entire intent-to-treat population, the patient exposure to agents that are not likely to be benecial to a select genotype should be limited. Thus, careful consideration of biomarkers (and surrogate markers) plays an important role in drug development and regulatory decisions.
