Bioequivalence and Bioavailability Forum • Narrowing, widening and typos

Narrowing, widening and typos [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2014-09-14 17:39 (4300 d 05:15 ago) – Posting: # 13507
Views: 5,928

Hi Prashant,

personally I support your reasoning. There were actually cases with bioinequivalent / suprabioavailable formulations which lead to the development of the BE-concept in the late 1970s. Phenytoin was one of them (warfarin and digoxin the others). The main issue with phenytoin is the non-linear PK which might lead to intoxications in steady state. This effect is (mainly) related to the AUC. Like ElMaestro I would also recommend a scientific advice.

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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 typosHelmut 2014-09-14 15:39
        
        Narrowing, widening and typos prashantmohite 2014-09-15 07:31