Bioequivalence and Bioavailability Forum • 3 period full replicate

3 period full replicate [RSABE / ABEL]

posted by d_labes – Berlin, Germany, 2015-06-25 10:52 (3458 d 21:08 ago) – Posting: # 14983
Views: 30,807

Dear Helmut et al.

I think it's a waste of time to discuss this bizarre opinion of a "leading European regulatory authority" in detail.
Scientifically there is IMHO not a single argument to underpin this opinion.
All details in Dan's quote are simply not true. Full stop.

Unfortunately it seems that scientific arguments don't play a big role in some regulators "opinions". And much, much more unfortunately regulators don't have to justify their judgements :crying:

.

So what's left? Your tip: "Don’t select them as a RMS!"
Another possibility would be to reactivate our Ol' pirate as a regulator :-D

BTW: The handling of the Concept paper on HVDs/HVDPs is revealing ...

—
Regards,

Detlew

Complete thread:

3 period full replicate Dr_Dan 2015-06-24 13:55 [RSABE / ABEL]
- 3 period full replicate ElMaestro 2015-06-24 14:11
- 3 period full replicate Helmut 2015-06-24 14:29
- 3 period full replicate d_labes 2015-06-24 14:38
  - 3 period full replicate Dr_Dan 2015-06-24 16:43
    - 3 period full replicate Helmut 2015-06-24 18:00
      - 3 period full replicate ElMaestro 2015-06-24 18:11
        
        3 period full replicate Helmut 2015-06-24 18:25
        
        3 period full replicated_labes 2015-06-25 08:52
        
        3 period full replicate ElMaestro 2015-06-25 10:37
        
        OT d_labes 2015-06-25 11:20
        
        OT ElMaestro 2015-06-25 11:54
        
        OT d_labes 2015-06-25 13:51
    - CVs (borderline OT) Helmut 2015-06-26 13:51
      - CVs (R, T) from pooled CV d_labes 2015-07-02 09:09
        
        Answering an unasked question Helmut 2015-07-02 13:03
        
        Answer to an unasked answer d_labes 2015-07-02 14:21
        
        Bloody typo! Helmut 2015-07-02 14:33
      - CVs (borderline OT) zizou 2015-07-05 19:20
        
        Degrees of freedom 3-period full replicate d_labes 2015-07-06 11:10
        
        Degrees of freedom 3-period full replicate ElMaestro 2015-07-06 11:59
        
        Degrees of freedom 3-period full replicate d_labes 2015-07-06 13:53
        
        Degrees of freedom 3-period full replicate zizou 2015-07-06 17:25
- The almighty oracle has spoken! Helmut 2015-07-23 23:54
  - Almighty oracle's mysterious saying d_labes 2015-07-24 08:23