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Ophthalmic drug administration is the administration of a drug to the eyes, most typically as an eye drop formulation. Topical formulations are used to combat a multitude of diseased states of the eye. These states may include bacterial infections, eye injury, glaucoma, and dry eye. [1]
In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.
United States: Although ICH GCP guidelines are recommended by the Food and Drug Administration (FDA), [4] they are not statutory in the United States. The National Institutes of Health requires NIH-funded clinical investigators and clinical trial staff who are involved in the design, conduct, oversight, or management of clinical trials to be ...
Syringe designed saline drops (e.g. Wallace Cameron Ultra Saline Minipod) are distributed in modern needle-exchange programmes as they can be used efficiently either by injection or ophthalmic (if the drug is potent in small doses) route of administer which is compared to intravenous use; by demonstration, the elimination of latanoprost acid ...
ICH E6 includes details of only a minimum list of contents and no other regulation or guideline provides a comprehensive list of TMF content. As a result of the inconsistencies that were developing across the sector, an industry group comprising 7 members from the GCP-RMA (Good Clinical Practice Records Managers Association) decided to develop ...
A medical professional administering nose drops Instillation of eye drops. A topical medication is a medication that is applied to a particular place on or in the body. Most often topical medication means application to body surfaces such as the skin or mucous membranes to treat ailments via a large range of classes including creams, foams, gels, lotions, and ointments. [1]
Melvin L. Rubin (1932–2014) (United States) was a retinal surgeon and educator; he created the Ophthalmic Knowledge Assessment Program (OKAP) that changed ophthalmic education, and was author of leading textbooks Optics for Clinicians and The Fine Art of Prescribing Glasses, as well as The Dictionary of Eye Terminology - currently in its 8th ...
Intravitreal injection was first mentioned in a study in 1911, in which the injection of air was used to repair a detached retina. [6] [7] [8] There were also investigations evaluating intravitreal antibiotics injection using sulfanilamide and penicillin to treat endophthalmitis in the 1940s, yet due to the inconsistency of results and safety concerns, this form of drug delivery was only for ...