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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.
The most common agents used to dilate the pupil are phenylephrine (2.5% in pediatrics or 10% in adults) and tropicamide (0.5% or 1%). While phenylephrine stimulates receptors that contract the dilator muscle of the pupil, [6] tropicamide blocks stimulation of the pupillary sphincter muscle to allow for relaxation. [7]
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 ...
The dye is naturally rinsed out of the eye by tears. Adults need no special preparation for the test; however children may need some preparation, depending on age, previous experiences, and level of trust. The list of equipment used by an optician is extensive and is often specified in jurisdiction specific Professional Standards of Practice. [18]
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 ...
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 ...