Bioequivalence and Bioavailability Forum

PE restriction for HVDs/HVDPs [Study Assessment]

posted by Helmut – Vienna, Austria, 2015-04-22 18:41 (3290 d 23:23 ago) – Posting: # 14733
Views: 11,141

Hi John,

❝ ❝ VSL’s post is ambiguous:

❝

❝ And guess what, he still hasn't replied :-|

❝

❝ But if he was talking about ref scaled, then why would he bring up 90 CI? Strange, actually scary...

Duno. That’s why I asked for more information. He/she didn’t mention a 90% CI, only told us

❝ Study is passed in CI

Maybe he/she meant the upper 95% CL of FDA’s approach (≤0)? BTW, since for the EMA scaling is capped at CV_WR 50% passing with a 90% CI and failing on the PE is very, very unlikely.

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

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Science Quotes

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 effects Helmut 2015-04-21 17:12
      - PE restriction for HVDs/HVDPs; testing effects jag009 2015-04-22 15:47
        
        PE restriction for HVDs/HVDPsHelmut 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 [Study As­sess­ment]

Complete thread:

PE restriction for HVDs/HVDPs [Study Assessment]