Nitrofurantoin BE study [Regulatives / Guidelines]

posted by pjs – India, 2015-08-03 12:06 (3242 d 04:29 ago) – Posting: # 15180
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Thanks for the response.

I also think the study should be conducted under fed condition. However for capsule of the same innovator, generic company has conducted both fed and fasted study UKPAR.

Guideline also states “SmPC recommends intake of the reference medicinal product on an empty stomach or irrespective of food intake, the bioequivalence study should hence be conducted under fasting conditions. 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.” Also Gastrointestinal reactions may also be minimised by adjustment of dosage and concomitant food intake is not necessary. As there is no mention that the product should be taken only with food i am confused.

Also as per the steps taken for assessment section in the mentioned UKPAR, the approval process has taken longer duration than usual for national submission. There could so many possible reasons for this delay in the approval but one of the reason could be deficiency regarding the type of the study fasting/fed conducted initially by applicant and opposite study required by the regulatory agency.


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