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Guidance Issuing OfficeCenter for Drug Evaluation and Research
This guidance discusses certain quality considerations for ophthalmic drug products (i.e., solutions, suspensions, emulsions, gels, ointments, and creams) intended for topical delivery in and around the eye. Specifically, the guidance discusses:
• Approaches to evaluating visible particulate matter, extractables and leachables, and impurities and degradation products.
• Use of in vitro drug release/dissolution testing as an optional quality control strategy for certain ophthalmic dosage forms.
• Recommendations for design, delivery, and dispensing features of container closure systems (CCSs).
• Recommendations for stability studies.