Bioequivalence and Bioavailability Forum

reference scaled bioequivalence [RSABE / ABEL]

posted by AngusMcLean – USA, 2010-11-07 15:55 (5304 d 00:28 ago) – Posting: # 6111
Views: 15,813

Sunday November 7, 201:

I discovered this slide from a presentation from Pharsight

From: 80-125% to ± 1.25^σ(Ref)/0.25

• Reference Intra-CV < 30% →   BE-range:   80 to 125%
  
• Reference Intra-CV = 35% →   BE-range: ≈ 77 to 130%
  
• Reference Intra-CV = 40% →   BE-range: ≈ 74 to 135%
  
• Reference Intra-CV = 45% →   BE-range: ≈ 71 to 141%
  
• Reference Intra-CV = 50% →   BE-range: ≈ 68 to 147%

I understand it is an interpretation of the direction of FDA thinking relating to extending the criteria for means ratio and confidence intervals for BE of highly variable drugs.

The observed ratio must be within 80-125%; the study design must be partially or fully replicated.

What do you think of it?

Angus

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Edit: Category changed. [Helmut]

Complete thread:

• reference scaled bioequivalenceAngusMcLean 2010-11-07 14:55 
  • reference scaled bioequivalence Helmut 2010-11-07 16:08
    • reference scaled bioequivalence AngusMcLean 2010-11-08 22:22
      • RSABE: FDA vs. EMA Helmut 2010-11-09 02:13
        • Farside CV relabelling d_labes 2010-11-09 10:42
          • Farside CV relabelling Helmut 2010-11-09 15:10
            • Laszlo's constant d_labes 2010-11-09 16:46
          • Farside CV relabelling AngusMcLean 2010-11-09 17:12
            • Widened calculations step by step d_labes 2010-11-09 19:48
              • Widened calculations step by step AngusMcLean 2010-11-09 20:46
                • ln vs. log Helmut 2010-11-09 22:07
                • ln on US calculators! d_labes 2010-11-10 08:31
                  • Spreadsheet addiction Helmut 2010-11-10 13:42
            • CV vs. sigma Helmut 2010-11-09 20:11
              • CV vs. sigma AngusMcLean 2010-11-09 20:57
                • log(e) vs. log(10) Helmut 2010-11-09 21:31
              • slide 15 of the Pharsight presentation SDavis 2010-11-19 18:02
        • one more ref. for the ref. list of RSABE yjlee168 2010-11-30 07:16
          • Great! Helmut 2010-11-30 15:44