Bioequivalence and Bioavailability Forum

Science ↔ Guidelines [Regulatives / Guidelines]

posted by Helmut  – Vienna, Austria, 2011-06-07 01:25 (5503 d 14:05 ago) – Posting: # 7080
Views: 11,335

My Capt’n!

❝ 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...

Ha! You dropped the start of the sentence: »It should be emphasised that no guideline can cover all eventualities, and common sense …«

❝ It is crystal clear, isn't it? When they speak of needs, I am pretty sure they mean something with coffee.

Don’t forget the whipped sweet cream on top.

❝ Or perhaps a forced parametric analysis when residuals are not normal. Or something like that.

Why not? To quote yourself:

Garbage in, garbage out.
It’s very very simple.

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

Well; I’m neither the investigator nor member of the trial staff – if you mean §4.8.3.

—
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:

• metformin steady state study jagankm 2011-06-01 11:19 
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            • Steady state (no accumulation) Ohlbe 2011-06-06 13:54
              • Science ↔ Guidelines Helmut 2011-06-06 14:06
                • Science ↔ Guidelines ElMaestro 2011-06-06 22:35
                  • Science ↔ GuidelinesHelmut 2011-06-06 23:25
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