This article examines five key facets of the topical ocular drug industry to highlight key challenges associated with ocular drug development.
- An understanding of ophthalmology and the scientific requirements for topical ophthalmic drugs and devices
- Development and manufacturing of ophthalmic drug products.
- Knowledge of US ophthalmology regulatory requirements
- Overall clinical drug development issues
- A thorough knowledge of ophthalmology clinical trial design and conducting clinical trials that meet regulatory guidelines
Regulatory Focus 14:47-52, 2009.