Bioequivalence and Bioavailability Forum • FDA: phenytoin = NTID?

FDA: phenytoin = NTID? [Regulatives / Guidelines]

posted by kvgreddy06 – India, 2014-09-26 16:17 (4287 d 15:01 ago) – Posting: # 13594
Views: 5,687

Hi Helmut,

❝ Do you have any references supporting your claim? FDA’s product specific guidances of 2008…

Recently we got a query from FDA.

FDA itself suggested “phenytoin is a narrow therapeutic index (NTI) drug, the Division of Bioequivalence currently recommends statistical analysis of bioequivalence study data using the reference-scaled average bioequivalence approach for NTI drugs as outlined in Warfarin guidance”

The OGD of phenytoin ER capsule is not available in current website, it was available in 2008.

Regards.
kvgr

Complete thread:

Phenytoin BE Limits prashantmohite 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