Bioequivalence and Bioavailability Forum

Steady state (no accumulation) [Regulatives / Guidelines]

posted by Ohlbe – France, 2011-06-06 15:54 (5128 d 15:46 ago) – Posting: # 7075
Views: 10,222

Dear Helmut,

❝ Agree with the former, but not the latter. From my little story: CVs for AUC_t ≈7 %, C_max ≈15 %, C_min¹ ≈75 %. According to the current NfG C_min is required – no scaling (EMA is considering scaling for HVDs/HVDPs if accumulation occurs as an alternative to multiple dose studies). For the usual stuff (AR 80–125%, α≤0.05, power 80%, PE 0.95) that would require increasing the sample size from 12 to 194 (!) in a 2×2 cross-over.

True, I forgot this part of the problem

Regards
Ohlbe

Complete thread:

• metformin steady state study jagankm 2011-06-01 11:19 [Regulatives / Guidelines] 
  • metformin steady state study Ohlbe 2011-06-01 11:31
  • metformin steady state study drgunasakaran1 2011-06-02 04:24
    • metformin steady state study Ohlbe 2011-06-02 08:56
    • metformin steady state study jagankm 2011-06-02 10:35
      • Steady state (no accumulation) Helmut 2011-06-03 14:58
        • Steady state (no accumulation) Ohlbe 2011-06-06 10:46
          • Steady state (no accumulation) Helmut 2011-06-06 13:05
            • Steady state (no accumulation)Ohlbe 2011-06-06 13:54
              • Science ↔ Guidelines Helmut 2011-06-06 14:06
                • Science ↔ Guidelines ElMaestro 2011-06-06 22:35
                  • Science ↔ Guidelines Helmut 2011-06-06 23:25
      • metformin steady state study kvgreddy06 2014-07-23 18:32