ABSTRACT
Drug development is a long and complicated process, involving the contributions and interactions of many persons over a considerable period of time. Some companies may choose to use an exploratory investigational new drug (IND) application to help in drug candidate selection. The dose and duration allowed in exploratory IND studies is more limited than in traditional first studies in humans and thus the amount of nonclinical data needed is also more limited than in traditional first IND studies in humans. The sponsor may choose to submit an IND, which includes a detailed clinical protocol with proposed initial and highest doses to be used, together with supporting data from in vitro studies and from animals, chemistry and manufacturing information, and data on the stability of the drug. If the overall recommendation is for approval, the Food and Drug Administration and the drug sponsor negotiate the wordings of the proposed product labeling/package insert, which describes safe and effective use of the product.
