Bioequivalence and Bioavailability Forum • Science ↔ Guidelines

Science ↔ Guidelines [Regulatives / Guidelines]

posted by ElMaestro – Denmark, 2011-06-07 00:35 (5497 d 22:54 ago) – Posting: # 7079
Views: 11,239

Dear Helmut,

I am rather confused now.

❝ I agree with Hermann’s statement about guidelines quite a while ago. :ok: I support keeping (t)his order:

Science (+ a drip of common sense)
Guidelines

"common sense" ?
It isn't defined in any EU guideline or any eudralex document. I don't know how to validate it if anyone can propose a way of measuring it. Of course it is extremely informative what this document tell us:
...Common sense and a clear focus on the needs of the regulatory authority assessor are the best guides...
It is crystal clear, isn't it? When they speak of needs, I am pretty sure they mean something with coffee. Or perhaps a forced parametric analysis when residuals are not normal. Or something like that.

Don't we all wish we could coerce or unduly influence?

Best regards,
EM.

Complete thread:

metformin steady state study jagankm 2011-06-01 11:19
- metformin steady state study Ohlbe 2011-06-01 11:31
- metformin steady state study drgunasakaran1 2011-06-02 04:24
  - metformin steady state study Ohlbe 2011-06-02 08:56
  - metformin steady state study jagankm 2011-06-02 10:35
    - Steady state (no accumulation) Helmut 2011-06-03 14:58
      - Steady state (no accumulation) Ohlbe 2011-06-06 10:46
        
        Steady state (no accumulation) Helmut 2011-06-06 13:05
        
        Steady state (no accumulation) Ohlbe 2011-06-06 13:54
        
        Science ↔ Guidelines Helmut 2011-06-06 14:06
        
        Science ↔ GuidelinesElMaestro 2011-06-06 22:35
        
        Science ↔ Guidelines Helmut 2011-06-06 23:25
    - metformin steady state study kvgreddy06 2014-07-23 18:32