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https://journals.sagepub.com/doi/pdf/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. Tre atment of anterior-
https://journals.sagepub.com/doi/full/10.1177/0192623307310955
Jan 01, 2008 · Safety Evaluation of Ocular Drug Delivery Formulations: Case Studies. Injectable Therapies. Most injectable therapies are used intravitreally, and there is a plethora of literature on the safety and pharmacokinetics of these formulations by this route, mostly conducted in rabbits. As mentioned above, Kenalog, the only commercially available TA ...Author: Brian G. Short
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4289909/
To overcome the ocular drug delivery barriers and improve ocular bioavailability, various conventional and novel drug delivery systems have been developed such as emulsion, ointments, suspensions, aqueous gels, nanomicelles, nanoparticles, liposomes, dendrimers, implants, contact lenses, nanosuspensions, microneedles, and in situ ...Author: Ashaben Patel, Kishore Cholkar, Vibhuti Agrahari, Ashim K Mitra
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3313063/
Feb 27, 2012 · Successfully Improving Ocular Drug Delivery Using the Cationic Nanoemulsion, Novasorb ... The main challenges in ocular drug delivery and key considerations to develop an ophthalmic preparation are listed in Table 1. ... The nonclinical development is divided into the safety evaluation and the pharmacokinetic studies. 4.1. SafetyAuthor: Frederic Lallemand, Philippe Daull, Simon Benita, Ronald Buggage, Jean-Sebastien Garrigue
https://www.sciencedirect.com/science/article/pii/S1359644618304288
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.Author: Evan A. Thackaberry, Florence Lorget, Cindy Farman, Vladimir Bantseev
https://www.sciencedirect.com/topics/medicine-and-dentistry/ocular-drug
Because of their great kinetic stability and controlled release properties, LNs can also be used as drug delivery systems to the posterior segment of the eye, thus reducing frequency of administration. To date, various studies have been performed concerning LNs for …
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/nonclinical-safety-evaluation-reformulated-drug-products-and-products-intended-administration
Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route October 2015. Download the Final Guidance Document. Final.
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