Nitrofurantoin BE study [Regulatives / Guidelines]

posted by drgunasakaran1  – 2015-08-02 14:56 (2314 d 23:27 ago) – Posting: # 15178
Views: 8,634

Dear Mr PJS,

» Now in the Smpc of the innovator of oral suspension (Furadantin) in pososlogy there is no specific mention of the drug intake with food. The statements included are “Gastrointestinal reactions may be minimised by taking the drug with food or milk, or by adjustment of dosage.” And “Increased absorption with food or agents delaying gastric emptying.” As per PIL “Nitrofurantoin Oral Suspension should be taken with food or milk.”
»
» For generic submission in EMA which study should be conducted fasting or fed or both?

EMA's Guideline on the Investigation of Bioequivalence states that "For products where the SmPC recommends intake of the reference medicinal product only in fed state, the bioequivalence study should generally be conducted under fed conditions."
Since SmPC of Furadantin states that “Gastrointestinal reactions may be minimised by taking the drug with food or milk, or by adjustment of dosage", I feel that you can conduct the study under fed conditions providing the above SmPC justification".

Dr S Gunasakaran MBBS MD
Disclaimer: The replies/posts are my personal opinions and it does not represent my company views on the same.

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