Safety Evaluation of Ocular Drug Delivery Formulations: Techniques and Practical Considerations

Toxicologic Pathology http://tpx.sagepub.com Safety Evaluation of Ocular Drug Delivery Formulations: Techniques and Practical Considerations
Brian G. Short Toxicol Pathol 2008; 36; 49 DOI: 10.1177/0192623307310955 The online version of this article can be found at: http://tpx.sagepub.com/cgi/content/abstract/36/1/49

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Toxicologic Pathology, 36:49-62, 2008 Copyright © 2008 by Society of Toxicologic Pathology ISSN: 0192-6233 print / 1533-1601 online DOI: 10.1177/0192623307310955

Safety Evaluation of Ocular Drug Delivery Formulations: Techniques and Practical Considerations
BRIAN G. SHORT From Allergan, Inc., Irvine, California, USA.
ABSTRACT Development of new drug candidates and novel delivery techniques for treatment of ocular diseases has recently accelerated. Treatment of anteriorsegment diseases has witnessed advances in prodrug formulations and permeability enhancers. Intravitreal, subconjunctival, and periocular routes of administration and sustained-release formulations of nanoparticles and microparticles, as well as nonbiodegradable and biodegradable implants to deliver drugs to the posterior segment of the eye, are becoming popular therapeutic approaches. Without adequate regulatory guidance for ocular drugs, such routes of administration and novel formulations can pose unique challenges to those involved in designing nonclinical programs, including considering clinical and nonclinical factors and choosing species, strains, and ocular toxicity parameters. Toxicologic

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