Bioequivalence and Bioavailability Forum

AUC more critical? [Regulatives / Guidelines]

posted by Helmut  – Vienna, Austria, 2014-09-14 17:42 (4305 d 15:53 ago) – Posting: # 13508
Views: 6,000

Hi nobody,

❝ ❝ Based on this feel that Cmax is of not particular importance in case of Phenytoin.

❝

❝ Hmmm, how about any safety concerns related to Cmax?

I don’t think so. Steady state profiles of phenytoin are pretty “flat”. IMHO, AUC is the killer.

Most neurologists are concerned about switching antiepileptic formulations. Below one of my early sins*. All of these formulations were approved and marketed in Austria in the early 1980s.

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• Nitsche V, Mascher H, and H Schütz
  Comparative bioavailability of several phenytoin preparations marketed in Austria
  Int J Clin Pharmacol Ther Toxicol 22(2), 104–7 (1984)

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


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Science Quotes

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