Bioequivalence and Bioavailability Forum • Narrowing, widening and typos

Narrowing, widening and typos [Regulatives / Guidelines]

posted by kvgreddy06 – India, 2014-09-13 09:18 (4303 d 01:58 ago) – Posting: # 13501
Views: 5,980

Dear Prashant,

As per USFDA,

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.

As my opinion is Cmax and AUC should be in limits 90.00 – 111.11 %,

Thanks,
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 typoskvgreddy06 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