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Home » FDA Guidance Shares Quality Considerations for Ophthalmic Drugs
FDA Guidance Shares Quality Considerations for Ophthalmic Drugs
The FDA’s newest draft guidance discusses quality considerations for ophthalmic drugs, including ways to assess impurities, evaluate visible contaminants, design containers and conduct stability studies.
The 15-page draft guidance shares ways to evaluate visible particulate matter, extractables and leachables from closed container systems as well as the use of in vitro drug release and dissolution testing for quality control.
When developing programs to evaluate product stability, sponsors of NDAs should consider that the stability of ophthalmic drugs can be affected by the orientation under which they are stored. The guidance advises that BLA submitters should conduct primary stability studies to determine how to store the product in real-time conditions.
Read the full draft guidance here.
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