Bioequivalence and Bioavailability Forum

t75% (reporting only?) [NCA / SHAM]

posted by Helmut  – Vienna, Austria, 2013-08-28 16:32 (4683 d 10:24 ago) – Posting: # 11371
Views: 12,371

Hi mittyri!

❝ According russian guide t_75% is calculated (chapter 6.1).

❝ So the question is: what can we do with this data?

❝ As you can see in chapter 7 (Statistical evaluation of bioequivalence) this parameter isn't used.

Interesting, didn’t notice that before! Chapter 6.1 and 6.2 calls for the T/R ratios of these PK metrics and Chapter 7 calls for BE assessment of AUC_t or AUC_∞ (AUC_τ,ss if applicable), C_max, C_max/AUC_t, C_max/AUC_∞ (or C_max/AUC_τ,ss).

❝ Would you explain this issue?

Your are closer to Russian regulators than I am. Duno, ask them. I would say simply report t_75% etc.

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


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Science Quotes

Complete thread:

• Russian Guidance – PK Data assay Karthikeyan 2013-08-27 13:54 [NCA / SHAM] 
  • Plateau-time etc. Helmut 2013-08-27 14:44
  • Russian Guidance – PK Data assay Dr_Dan 2013-08-27 15:39
    • Russian Guidance – PK Data assay Helmut 2013-08-27 16:31
      • t75% Dr_Dan 2013-08-27 16:56
        • t75% Helmut 2013-08-27 17:37
          • t75% mittyri 2013-08-28 09:51
            • t75% (reporting only?)Helmut 2013-08-28 14:32
    • Partial AUC? Helmut 2013-08-28 17:42
      • Partial AUC? Dr_Dan 2013-08-28 21:08
        • Partial AUC? Karthikeyan 2013-08-29 14:04