Nitrofurantoin BE study [Regulatives / Guidelines]

posted by Relaxation  – Germany, 2021-06-15 12:10 (418 d 15:56 ago) – Posting: # 22413
Views: 1,945

Hi.

For the interested, the current (draft:-)) version of PSG_009175 is dated May 2021.

»Whether BE Study to be performed with 25 mg ( 5mL) or 100 mg ( 20 mL ) ?

For both, fasted and fed trial given in the product-specific BE guidance:
Strength: 25 mg; 5 mL

Best regards.

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