Bioequivalence and Bioavailability Forum

Rant [Regulatives / Guidelines]

posted by nobody – 2014-10-15 20:26 (4275 d 10:22 ago) – Posting: # 13719
Views: 10,096

In my opinion these guideline things are highly political, make an educated guess how many of the guys involved know what alpha is, beware of an alpha inflation.

And then in the final round of drafting some industry-politics-lobby guys come in: "Unfair! we need a second chance, if we fail just by...ehhh... being to dull to calculate the sample size chance, we want an add-on!"

...and suddenly you end up with such home-bake stuff. It's the same on all levels, from small town politics to "we save the Euro" nonsense.

Time to leave office and have little fresh air!

Complete thread:

• Mexico BE – add-on design? nobody 2014-10-15 15:38 
  • Mexico BE – add-on design? Helmut 2014-10-15 15:50
    • Mexico BE – add-on design? nobody 2014-10-15 16:47
      • Rant Helmut 2014-10-15 17:38
        • Rantnobody 2014-10-15 18:26
      • Mexico BE – add-on design? nobody 2014-10-16 10:22
        • Mexico BE – add-on design? Risherd 2014-10-24 00:26
          • Mexico BE – add-on design? Helmut 2014-10-24 00:59
          • Mexico BE – add-on design? nobody 2014-10-24 08:46
            • Mexico BE – add-on design? Helmut 2014-10-24 19:05
            • Mexico BE – add-on design? xtianbadillo 2016-04-07 18:54
              • Mexico BE – add-on design? Mahesh M 2016-04-11 09:42
                • No English translation Helmut 2016-04-11 13:29