Bizec, Jean-Claude, Glogovac, Milica, Gromek, Kamila, Prause, Maarten, Winkler, Gian Christian, Milton, Mark, Newton, Ronald and Lovsin Barle, Ester (2017) Determination of Permitted Daily Exposure for Topical Ocular Drugs. Determination of Permitted Daily Exposure for Topical Ocular Drugs (00). pp. 1-9. ISSN 1083-7450

Abstract

Limits for the carryover of product residues should be based on toxicological evaluation such as described in the European Medicines Agency (EMA) Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA, 2014).Currently no guidance on setting PDE is available for ocular drug substances. The purpose of this study was to identify a method for calculating a PDE value for topically administered ocular drugs (PDEocular). The method can be applied in cross-contamination risk assessment during manufacturing of drugs intended for topical ocular administration, as well. We have examined the pharmacokinetic and pharmacodynamic (PKPD) properties of the drugs administered topically to the eyes and compared them to the PKPD parameters of systemically administered drugs. Furthermore we examined the therapeutic doses and critical effects of drugs administered topically to the eyes. In this manuscript we are proposing a method for calculation of PDEocular for manufacturing of drugs in a facility dedicated for ocular drugs. Additionally we are proposing a conversion factor for systemically administered drugs that are manufactured before the ocular drug.

Item Type:	Article
Keywords:	Ocular drug, manufacturing, PDE, systemic application, topical application
Date Deposited:	13 Jun 2017 00:45
Last Modified:	13 Jun 2017 00:45
URI:	https://oak.novartis.com/id/eprint/29351