ABSTRACT

Preclinical proof-of-concept studies typically provide the scientic rationale for further development of a drug candidate in a clinical setting and are usually conducted as basic research using good scientic practices with the goal of publication and enhancing basic knowledge in the eld of study. Translating this promising research into a full drug pharmaceutical/clinical development program requires activities aimed at determining the safety of the drug product and its components, the efcacy, and most relevant to this review, the ability to relate these biological effects to specic chemical and physical attributes of the nal product (Zamboni et al. 2012). These pharmaceutical/ clinical development studies are based on the laws governing human and veterinary medicines, as well as the expectations of the regulatory agencies responsible for marketing approval.