Bioequivalence and Bioavailability Forum

PE restriction for HVDs/HVDPs; testing effects [Study Assessment]

posted by Helmut – Vienna, Austria, 2015-04-21 19:12 (3282 d 16:40 ago) – Posting: # 14729
Views: 11,362

Hi John,

❝ You guys are messing with me... If the T/R Ratio is <0.8 or >1.25, how can you generate a 90 CI that is within 80.00 – 125.00 since the 90% CI consists of (PE ± values)?

If we are dealing with unscaled ABE, ElMaestro’s answer (and your doubt) is correct: No way.

VSL’s post is ambiguous:

❝ Study is passed in CI but mean T/R ratio is not within the 0.80-1.25.

If the study was reference-scaled, the (implied) BE limits may be much wider (my answer).
Example in FDA’s flavor: CV_WR 60%, implied limits 60.96–164.04%, CI 97.00–162.00%; would pass (CI within limits), but fail due to the PE of 125.36 >125.00%.

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Helmut Schütz

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Complete thread:

Study Results VSL 2015-04-20 21:46 [Study Assessment]
- Study Results ElMaestro 2015-04-20 23:47
  - upper CL < PE Helmut 2015-04-21 00:39
- PE restriction for HVDs/HVDPs; testing effects Helmut 2015-04-21 00:24
  - PE restriction for HVDs/HVDPs; testing effects jag009 2015-04-21 16:49
    - PE restriction for HVDs/HVDPs; testing effectsHelmut 2015-04-21 17:12
      - PE restriction for HVDs/HVDPs; testing effects jag009 2015-04-22 15:47
        
        PE restriction for HVDs/HVDPs Helmut 2015-04-22 16:41
  - GMR outside the limits when using ABEL Averroes 2017-05-19 11:53
    - Regulations ≠ Science Helmut 2017-05-19 14:07
      - Regulations ≠ Science Averroes 2017-05-22 20:51

PE restriction for HVDs/HVDPs; testing effects [Study As­sess­ment]

Complete thread:

PE restriction for HVDs/HVDPs; testing effects [Study Assessment]