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Figure 1.0 - Basic anatomical features of the human eye. 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.
The International Joint Commission on Allied Health Personnel in Ophthalmology (IJCAHPO) is an American nonprofit professional association for Allied Ophthalmic Personnel (AOP). Founded in 1969, the IJCAHPO provides certification and education programs for persons in the ophthalmology field.
A series of unsuccessful and ineffective clinical trials in the past were the main reason for the creation of ICH and GCP guidelines in the US and Europe. These discussions ultimately led to the development of certain regulations and guidelines, which evolved into the code of practice for international consistency of quality research.
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 ...
Owing to the importance of the IB in maintaining the safety of human subjects in clinical trials, and as part of their guidance on good clinical practice (GCP), the U.S. Food and Drug Administration (FDA) has written regulatory codes and guidances for authoring the IB, and the International Conference on Harmonisation (ICH) has prepared a ...
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 ...
Using a phoropter to determine a prescription for eyeglasses. An eyeglass prescription is an order written by an eyewear prescriber, such as an optometrist, that specifies the value of all parameters the prescriber has deemed necessary to construct and/or dispense corrective lenses appropriate for a patient.