Bioequivalence and Bioavailability Forum • Nitrofurantoin BE study

Nitrofurantoin BE study [Regulatives / Guidelines]

posted by AB661 – India, 2021-06-15 11:38 (1431 d 16:33 ago) – Posting: # 22412
Views: 5,058

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:

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 studyAB661 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 study Relaxation 2021-06-16 12:59