Toward the practical implementation of eye-related bioavailability prediction models

• Cell-based primary permeability screening.
• Tissue-/tissue equivalent-based secondary permeability screening.
• Eye-related bioavailability/bioequivalence.
• Efficient process of reformulated ophthalmic product development and registration.

The development and registration of reformulated ophthalmic products (OPs) requires eye-related bioavailability (BA) assessments. Common BA algorithms associated with other routes of application, such as the oral route, cannot be easily applied to eye-related BA testing. Here, we provide an analysis of the current literature and suggestions for further directions in the development of high-capacity, cost-effective, and highly predictive nonclinical models of eye-related drug BA. One, or a combination of these models, has the potential for routine use in research laboratories and/or the pharmaceutical industry to overcome various obstacles in reformulated OP development and registration.

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