Bioequivalence and Bioavailability Forum

Nonlinear nightmare [General Sta­tis­tics]

posted by Helmut  – Vienna, Austria, 2013-11-26 15:32 (4222 d 11:23 ago) – Posting: # 11972
Views: 15,139

Hi John,

❝ Have you goofed around with DDI before (drug interaction->inhibition)?

Yes, but always in steady state and not with CBZ.

❝ You can't run carbamazepine single dose BE due to autoinduction.

No? Single dose studies are recommended in all of FDA’s carbamazepine-guidances. I don’t think that full autoinduction is seen in the first dose. It will take the enzymes a while to tune up. That’s why I started to play around with time-dependent increase of clearance.

Regulators differ in their opinions whether CBZ is an NTID. Even if the conventional 80–125% are applicable to C_max and AUC, pAUC would be a sensitive PK metric being able to discriminate between formulations with different absorption rates.

❝ We ran the BE program before and went with multiple-dose studies with no washout period like 8 yrs ago. I hope no one did...

Oh boy…

❝ I don't have Laszlo's paper so I don't know the details.

You’ve got mail.

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


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Science Quotes

Complete thread:

• Simulation of data to predict Steady state cakhatri 2013-11-24 10:13 [General Sta­tis­tics] 
  • Nonparametric superposition Helmut 2013-11-24 14:30
    • Nonparametric superposition jag009 2013-11-24 23:13
      • Nonlinear nightmare Helmut 2013-11-25 02:56
        • Nonlinear nightmare jag009 2013-11-25 17:43
          • Nonlinear nightmareHelmut 2013-11-26 14:32
            • Nonlinear nightmare jag009 2013-11-26 16:00
              • OT: Vienna Helmut 2013-11-26 16:27
                • OT: Vienna jag009 2013-11-26 17:29
                  • OT: Vienna Helmut 2013-11-27 13:04
    • Conc at dosing interval jag009 2013-11-25 17:48
      • Conc at dosing interval Helmut 2013-11-26 15:01
        • Conc at dosing interval jag009 2013-11-26 17:31
          • Conc at dosing interval Helmut 2013-11-27 13:10
            • Conc at dosing interval jag009 2013-11-27 20:00
            • Passing SD and Failing MD luvblooms 2013-11-28 09:19
              • Passing SD and Failing MD Helmut 2013-11-29 17:29
                • Passing SD and Failing MD luvblooms 2013-11-29 18:57
                  • Cτ predictive of Cmin Helmut 2013-11-30 17:25