Bioequivalence and Bioavailability Forum

Nitrofurantoin BE study [Regulatives / Guidelines]

posted by Relaxation  – Germany, 2021-06-16 14:59 (1272 d 13:40 ago) – Posting: # 22417
Views: 4,301

Hi AB661.

You are right. I was to quick and as they stated "Strength: 25 mg; 5 mL" and not "Strength: 25 mg/5 mL" this appeared to me as a dose recommendation. Should have checked the SmPC

I personally would search for the standard highest dose (which is 100 mg here according to the SmPC, right), but you may want to check initially whether exposure is proportional to dose, discuss which dose actually is needed to have sufficient concentrations with the analytical method (or if the method can be improved rather than discuss supra-therapeutic doses) and which dose is acceptable in healthy subjects for safety reasons.

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 study Relaxation 2021-06-15 12:10
                • Nitrofurantoin BE study AB661 2021-06-16 08:13
                  • Nitrofurantoin BE studyRelaxation 2021-06-16 12:59