ABSTRACT
The usual goal of ophthalmic drug delivery system research is to develop an improved therapeutic regimen. Some form of performance testing is necessary to determine if the goal has been met, and such testing may involve federal regulatory considerations. If the drug delivery researcher is only interested in the in vitro performance of his or her system and/or its in vivo performance in laboratory research animals for research and publication purposes, federal regulations can largely be ignored. However, if the delivery system is being developed for testing and use in human and/or veterinary medicine, a knowledge of the regulations governing animal and human testing and ultimately the application to market such a pharmaceutical drug product will be essential.
