Bioequivalence and Bioavailability Forum

Range [BE/BA News]

posted by Helmut  – Vienna, Austria, 2022-04-11 18:07 (345 d 08:42 ago) – Posting: # 22927
Views: 2,355

Hi Ohlbe,

❝ I guess it depends what they mean by "range". Are they using the word in its statistical meaning (difference between the largest and smallest values) or in its lay language meaning (limits between which something varies) ? I suspect the latter: lowest and highest observed T_max values.

You mean that we only have to report the minimum and maximum t_max of T and R? But how should we understand this:

Comparable  median (≤ 20% difference) and  range for T_max.

How to decide what is ‘comparable’? Ask ten people and get twelve answers?
The range it given in the section ‘Bioequivalence assessment’. We report other stuff as well (λ_z/t_½, AUC_0–t/AUC_0–∞, ). So why does it sit there?

—
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Helmut Schütz


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Complete thread:

• EMA: New product-specific guidances Helmut 2022-04-08 15:17 
  • How would you implement it? ElMaestro 2022-04-09 11:45
    • Confuse a Cat Inc. Helmut 2022-04-09 18:40
      • Confuse a Cat Inc. ElMaestro 2022-04-09 21:47
        • Confuse a Cat Inc. Ohlbe 2022-04-11 11:29
          • Confuse a Cat Inc. Helmut 2022-04-11 13:59
            • Range Ohlbe 2022-04-11 15:48
              • RangeHelmut 2022-04-11 16:07
                • Range Ohlbe 2022-04-11 16:20
              • Range Helmut 2022-07-28 14:43
        • So many questions, so few answers Helmut 2022-04-11 13:03
        • Preliminary simulations Helmut 2022-04-30 14:59
          • Preliminary simulations ElMaestro 2022-04-30 19:10
            • Preliminary simulations Helmut 2022-05-01 15:56
        • Simulated distributions Helmut 2022-05-02 13:43