Key Challenges to US Topical Ocular Drug Development
By Raymond A. Huml, MS, DVM, RAC, Cadmus Rich, MD, MBA, and Kamali Chance, MPH, PhD, RAC
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.
