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Translation From Ophthalmic Research to Ophthalmic Products
Gary D Novack1, William J Brock2, Audrey R Schupp3
1From the PharmaLogic Development, Inc. (G.D.N.), San Rafael, California, USA; Department of Ophthalmology & Vision Science (G.D.N.), University of California School of Medicine, Davis, California, USA.
Purpose:
To provide guidance primarily for the academic researcher for the translation from research of novel ophthalmic drugs for improved patient treatment to early-stage development including clinical trials.
Methods:
Based upon available guidelines and the authors' extensive experience in developing novel products, the authors present the requirements for chemistry (both drug substance and formulated drug product), nonclinical (pharmacology, pharmacokinetics, and toxicology), clinical and regulatory development.
Conclusion:
Development of successful novel ophthalmic products is a structured, sequential, and interactive scientific process.
