Bioequivalence and Bioavailability Forum • overgeneralization ????

overgeneralization ???? [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2013-02-21 13:17 (4862 d 11:09 ago) – Posting: # 10091
Views: 10,252

Hi Luv,

❝ ❝ • Worst: A strong tendency to bend the rules (“make” analytical batches valid, dealing with outliers, etc.).

❝

❝ […] Now coming to the rules/guidance (except “make” analytical batches valid, dealing with outliers) aren't they non binding recomendations :cool: .

Of course they are – I make my money dealing with problems which are generally non-standard. I meant intentionally deviating from GLs – without justifications, not searching scientific advice, etc. Simply bending the rules hoping for not being discovered. There is a fine line between thoughtlessness and fraud.

❝ We have followed the same in our protocols and till now not received any query on the same (blame it to 30 minute review window)

Oh, I always thought it is one hour?

❝ FDA prefers the same thing, got some queries on the same and was suggested to do it the EMEA way.

What – exactly – do you mean by “the EMEA way”?

❝ Now how about ER/MR/XR formulations as per the current guidelines??? 2 times median Tmax or τ (dosing interval)?

I use the dosing interval. Was too lazy now to look it up in GLs.

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

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

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 horsepower Helmut 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