Bioequivalence and Bioavailability Forum • Phenytoin BE Limits

Phenytoin BE Limits [Regulatives / Guidelines]

posted by prashantmohite – India, 2014-09-11 17:20 (4305 d 22:21 ago) – Posting: # 13483
Views: 6,748

Dear All,

Can i go for widened BE limits (80 – 125 5) in case of Cmax for Phenytoin molecule for EU submission.

Thanks in advance.

Regards,

Prashant

Complete thread:

Phenytoin BE Limitsprashantmohite 2014-09-11 15:20
- Phenytoin BE Limits Ohlbe 2014-09-11 17:57
  - The other way around? ElMaestro 2014-09-11 19:00
    - Narrowing, widening and typos Ohlbe 2014-09-11 19:25
      - Narrowing, widening and typos prashantmohite 2014-09-12 06:21
        
        Narrowing, widening and typos nobody 2014-09-12 10:30
        
        Narrowing, widening and typos kvgreddy06 2014-09-13 07:18
        
        FDA: phenytoin = NTID? Helmut 2014-09-14 15:24
        
        FDA: phenytoin = NTID? kvgreddy06 2014-09-26 14:17
        
        AUC more critical? Helmut 2014-09-14 15:42
        
        AUC more critical? nobody 2014-09-14 18:31
        
        Narrowing, widening and typos Helmut 2014-09-14 15:39
        
        Narrowing, widening and typos prashantmohite 2014-09-15 07:31