ABSTRACT
Often the development of background biopharmaceutic and pharmacokinetic data for a new drug is looked upon as part of the necessary obstacles that must be overcome in the Notice of Claimed Investigational Exemption for a New Drug (IND) and later the New Drug Application (NDA) process. Rather, this process should be looked upon as an opportunity, if properly utilized, to develop a body of information that should support the ongoing clinical studies of the IND Phase III process. In addition, if unexpected results develop in population subsets during Phase III or in any post-NDA Phase IV or surveillance studies, properly executed IND studies may provide adequate information to contain the problem.
