Dose Finding Based on Preclinical Studies

Abstract

Before it can ever become a new drug, the candidate starts as a small molecule generated through a synthetic process or as a protein or antibody purified from a cell culture or from a modified animal or egg. There is often some biological theory that supports the creation of this candidate. It might be based upon inserting a specific human gene into the DNA of the culture, or some specific configuration of the small molecule that is designed to “fit” into a three-dimensional structure on the surface of a cell known as a receptor. It might, however, be a candidate generated by a mass process that creates a large number of different molecules of similar structure, that are then tested in a screen where microtubules contain specific types of cultured cells designed to “respond” in some measurable way to a “hit”.