Bioequivalence and Bioavailability Forum • Intellectual horsepower

Intellectual horsepower [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2013-02-19 22:49 (4863 d 22:08 ago) – Posting: # 10070
Views: 10,773

Hi John,

❝ ❝ • Mean t_max of what?

❝

❝ Oh they did write "2 x mean Tmax of reference".

Doesn’t mean a thing unless one defines what the reference is. Please see again my #1/#2 above.

❝ I can see that if it's not a guidance requirement, but they should adhere to the guidance when the sponsor said it's for FDA ANDA…

Yep. I’m fed up with brainless protocols (and reports). I’m the last person taking guidances literally, but one has to understand them first if one intentionally [sic] wants to deviate from them.

Oops, \(\overline{x}\) instead of \(\widetilde{x}\). Sorry.*
Two-Stage rSABE study. Unknown patient’s risk; no statistical method published? Sorry.*
Concentrations below the LLOQ used in the evaluation. Sorry.*
λ_z from t_max to t_last, crossing three phases. Not terminal? Oops, sorry.*
≈ ∞

We can change it.

—
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Helmut Schütz

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Complete thread:

FDA dropout guideline for Emesis jag009 2013-02-19 16:16 [Regulatives / Guidelines]
- Median tmax Helmut 2013-02-19 17:49
  - Median tmax jag009 2013-02-19 19:49
    - Median tmax Helmut 2013-02-19 20:28
      - Median tmax jag009 2013-02-19 21:18
        
        Intellectual horsepowerHelmut 2013-02-19 21:49
        
        Intellectual horsepower jag009 2013-02-19 22:45
        Intellectual horsepower jag009 2013-02-20 16:12
        
        Intellectual horsepower Helmut 2013-02-20 17:03
        
        Intellectual horsepower jag009 2013-02-20 22:05
      - Median tmax luvblooms 2013-02-20 05:03
        
        Sorry for the overgeneralization Helmut 2013-02-20 16:54
        
        overgeneralization ???? luvblooms 2013-02-21 05:23
        
        overgeneralization ???? Helmut 2013-02-21 12:17
        overgeneralization ???? jag009 2013-02-21 16:55
  - Median tmax intuitivepharma 2013-02-28 13:05
    - Median tmax from pilot studies Helmut 2013-02-28 14:02