The safety evaluation of ocular long-acting delivery (LAD) technologies is a nascent field. Here, we detail the challenges in assessing the safety of novel LAD technologies, and well as the most common types of toxicity encountered during early toxicity testing. A detailed understanding of the route of administration, pharmacology, and functionality and/or pharmacokinetics (PK) of the LAD, along with all of its component parts, including the active pharmaceutical ingredient and excipients, is crucial for the successful development of next-generation long-acting ocular therapeutics.
机构:
Genentech Inc, Small Mol Pharmaceut Sci, One DNA Way, San Francisco, CA 94080 USAGenentech Inc, Small Mol Pharmaceut Sci, One DNA Way, San Francisco, CA 94080 USA
Laramy, Matthew N. O'Brien
Nagapudi, Karthik
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机构:
Genentech Inc, Small Mol Pharmaceut Sci, One DNA Way, San Francisco, CA 94080 USAGenentech Inc, Small Mol Pharmaceut Sci, One DNA Way, San Francisco, CA 94080 USA