Translation From Ophthalmic Research to Ophthalmic Products.
Where this comes from
- Record sourced from PubMed, PMID 40349814.
- Also identified by DOI 10.1016/j.ajo.2025.05.001.
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Abstract
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. 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. Development of successful novel ophthalmic products is a structured, sequential, and interactive scientific process.
Medical subject headings
- Drug Development
- Eye Diseases
- Ophthalmic Solutions
- Ophthalmology
- Translational Research, Biomedical