Bioequivalence and Bioavailability Forum

Regulators truncated [NCA / SHAM]

posted by d_labes  – Berlin, Germany, 2009-06-18 11:26 (5797 d 23:36 ago) – Posting: # 3872
Views: 31,830

Dear Ohlbe, dear Jaime, dear all,

let me share some experience with regulators in the EMEA. In a recent submission of a BE study with a long half-life product (t_1/2 from literature about 50-70 h) we submitted an evaluation with AUC(0-72h), C_max and t_max as metrics, the typical truncated area setting.

Regulators response:
The Germans asked for AUC(0-inf)!
The French asked for lamda_Z (k_el) and t_1/2!

Hopefully they will not ask for residual area <20% .

Complete thread:

• Calculation of AUC0-72 Sasi 2008-06-10 10:44 
  • Calculation of AUC0-72 Jaime_R 2008-06-10 12:18
    • Calculation of AUC0-72 Ohlbe 2008-06-10 17:28
      • Calculation of AUC0-72 Jaime_R 2008-06-10 18:45
        • Regulators truncatedd_labes 2009-06-18 09:26
          • Regulators truncated Ohlbe 2009-06-18 10:37
          • Regulators truncated Helmut 2009-06-18 14:49
            • Regulators truncated d_labes 2009-06-18 15:26
              • Regulators truncated Helmut 2009-06-18 15:44
                • Regulators truncated ElMaestro 2009-06-19 22:16
                  • Regulators truncated Helmut 2009-06-19 22:35
          • Luke 23:34 ElMaestro 2009-06-18 14:50
      • Calculation of AUC0-72 d_labes 2008-09-05 15:00
        • Calculation of AUC0-72 Helmut 2009-01-26 16:24
          • Calculation of AUC0-72 d_labes 2009-01-26 16:57
            • Calculation of AUC0-72 Helmut 2009-01-26 17:20
              • The missing 72h d_labes 2009-01-27 11:48
                • The missing 72h Ohlbe 2009-01-28 00:00
                  • sensitivity analyses ? martin 2009-01-28 08:26
                  • Regulators ways are inscrutable d_labes 2009-01-28 09:54
                    • Regulators ways are inscrutable (at least the French) Ohlbe 2009-01-28 10:16
                • The missing 72h ElMaestro 2009-01-28 14:32
                  • Page 3848 of 221 d_labes 2009-01-28 14:51
                • Partial AUC calculation Astea 2017-03-11 20:14
                  • Partial AUC calculation mittyri 2017-03-16 19:46
  • Calculation of AUC0-72 PharmCat 2022-12-21 20:49