Bioequivalence and Bioavailability Forum

RSABE… [Regulatives / Guidelines]

posted by Loky do – Egypt, 2021-02-24 16:30 (1153 d 17:15 ago) – Posting: # 22230
Views: 2,694

Hi Dear Helmut,

Many thanks for your reply

❝ Which book are you referring to?

❝

❝ For the FDA you can apply RSABE for any PK metric (AUCs, partial AUCs, C_max, ) if its \(\small{s_{\textrm{wR}}\geq 0.294\;(CV_{\textrm{wR}}\geq\approx0.300469\ldots)}\)

❝ If \(\small{s_{\textrm{wR}}<0.294}\) you have to evaluate the respective PK metric for ABE.

I didn't find this statement in FDA guidance for bioequivalence studies just in progesterone guidance so, is it enough to refer to this guide while submitting the study to regulatory (as the intrasubject variability CV% equal 57%, partially replicate design), or is there another guide would support this way? please advice?

Thanks in advance

Complete thread:

• Scaling/Widening of AUC Researcher101 2021-02-23 20:40 
  • Scaling/Widening of AUC Loky do 2021-02-24 13:13
    • RSABE… Helmut 2021-02-24 14:46
      • RSABE…Loky do 2021-02-24 15:30
        • RSABE… Helmut 2021-02-24 15:47
  • Scaling/Widening of AUC Helmut 2021-02-24 15:29
    • Scaling/Widening of AUC Loky do 2021-02-24 16:13
    • Scaling/Widening of AUC dshah 2021-03-16 06:39
      • Scaling/Widening of AUC Helmut 2021-03-16 13:55