Bioequivalence and Bioavailability Forum • OT: Blume/Mutschler

OT: Blume/Mutschler [🇷 for BE/BA]

posted by Helmut – Vienna, Austria, 2019-04-25 17:32 (1821 d 00:28 ago) – Posting: # 20233
Views: 12,171

Hi nobody,

❝ WOW, somebody bought that! :-D

Though I don’t use it any more I still like the idea behind. At a conference in Toronto 1992 I showed the first file to guys (no gals at that time) of the FDA and told the story that ⅓ of German pharmacists are already trained on BE. Jaws dropped.

As an ol’ salt you know it but for the others: The ZL sent polite letters to manufacturers asking for information (the original evaluation which lead to the approval as well as study data allowing recalculation). Observations:

Some companies refused. Consequently in the collection there was an empty page stating just the name of the product and that the company didn’t provide any information. Very bad idea.
Comparing different products you could see that the same study was used numerous times. Hey, the file was sold.
Sometimes you see a lot of rotten pasta and the one “perfect” study. At that time was what is now.
Sometimes the reported CI didn’t match the calculation of the ZL.

—
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:

Graphing Mean PK profile roman_max 2019-04-23 16:01
- Graphing Mean PK profile Shuanghe 2019-04-23 18:31
  - Graphing Mean PK profile roman_max 2019-04-24 12:29
- Graphing Mean PK profile Helmut 2019-04-23 22:23
  - Graphing Mean PK profile nobody 2019-04-24 11:23
    - Graphing Mean PK profile Helmut 2019-04-24 11:49
      - Graphing Mean PK profile nobody 2019-04-24 11:53
        
        Graphing Mean PK profile Helmut 2019-04-24 12:32
        
        Graphing Mean PK profile nobody 2019-04-24 12:49
  - Graphing Mean PK profile roman_max 2019-04-24 12:36
    - Graphing Mean PK profile Helmut 2019-04-24 13:50
      - Graphing Mean PK profile nobody 2019-04-24 14:15
        
        Graphing Mean PK profile Helmut 2019-04-24 14:41
        
        Pasta Ohlbe 2019-04-25 12:47
        
        Pasta nobody 2019-04-25 14:36
        Spaghetti Viennese Helmut 2019-04-25 14:39
        
        Spaghetti Viennese nobody 2019-04-25 15:08
        
        OT: Blume/MutschlerHelmut 2019-04-25 15:32
        
        OT: Blume/Mutschler nobody 2019-04-25 15:43
  - A lie is a lie is a lie ... d_labes 2019-04-25 19:59