Bioequivalence and Bioavailability Forum • Nitrofurantoin BE study

Nitrofurantoin BE study [Regulatives / Guidelines]

posted by AB661 – India, 2021-06-15 11:38 (1038 d 13:39 ago) – Posting: # 22412
Views: 2,894

Dear All,

OGD BE recommendation recently updated. As per New guidance there are two studies ( fasting & Fed) need to be performed. Earlier only fasting study recommended. In current guidance for Dose of Suspension for BE study not mentioned. Whether BE Study to be performed with 25 mg ( 5mL) or 100 mg ( 20 mL ) ?

With regards
AB661

Complete thread:

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