Bioequivalence and Bioavailability Forum

Nitrofurantoin BE study [Regulatives / Guidelines]

posted by Relaxation  – Germany, 2021-06-15 14:10 (1040 d 00:12 ago) – Posting: # 22413
Views: 2,855

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.

Complete thread:

• Nitrofurantoin BE study pjs 2015-07-30 08:55 [Regulatives / Guidelines] 
  • Nitrofurantoin BE study drgunasakaran1 2015-08-02 14:56
    • Nitrofurantoin BE study pjs 2015-08-03 10:06
  • Nitrofurantoin BE study pjs 2015-08-07 04:10
    • Nitrofurantoin BE study pjs 2015-08-27 15:36
      • Nitrofurantoin BE study Dr_Dan 2015-08-28 09:15
        • Nitrofurantoin BE study pjs 2015-08-28 10:37
          • Nitrofurantoin BE study Dr_Dan 2015-08-31 18:19
            • Nitrofurantoin BE study AB661 2021-06-15 09:38
              • Nitrofurantoin BE studyRelaxation 2021-06-15 12:10
                • Nitrofurantoin BE study AB661 2021-06-16 08:13
                  • Nitrofurantoin BE study Relaxation 2021-06-16 12:59