Applying physiological and biochemical concepts to optimize biological drug development.

Posology--the science of dose and regimen--is a critical part of drug development. It is concerned with ensuring that patients experience significant clinical benefit without intolerable adverse effects. It has become apparent, in the case of certain biologics, that one can directly quantitate occupancy or target capture and relate these to clinical responses. With mathematical models that integrate binding concepts with clinical effects, potential posologies can be quickly explored through simulation, thereby liberating research teams from the traditional constraints and simultaneously stimulating innovation.