ABSTRACT
International Conference on Harmonization (ICH) is a project involving regulatory and industry representatives of the major pharmaceutical marketplaces in the world; the European Union, Japan, and the United States. In order for a drug product to be marketed in the United States, it must be approved by the United States Food and Drug Administration. For drugs intended for local delivery, as in the eye, ICH requirements call for a complete nonclinical assessment of the toxicologic, pharmacokinetic, and toxico-kinetic profile of the drug systemically, but also after ocular delivery. Pharmacokinetic studies are important in the development of local ocular drug delivery. Although a benefit of ocular drug delivery is the ability to achieve higher intraocular drug concentrations by avoiding the blood-retinal and blood–aqueous barriers. The objective of a clinical research program is to demonstrate that a drug is safe and effective in the treatment or prophylaxis of a disease.
