Data integrity? [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2018-01-16 01:16 (2085 d 03:55 ago) – Posting: # 18174
Views: 2,628

Hi ElMaestro,

❝ "because of reasons" :-D

❝ etc. etc. etc.

❝ Yes, life would be easier if the guy using the data you are submitting would be as IT-literate as you are.

I have no technical problems preparing the data in this format. What I find hard to swallow is that I
  1. have to manipulate (!) the data (my files contain the string BQL for all values <LLOQ after tmax) and
  2. have no means to give actual sampling times.
Concerning #1 hopefully HC’s software is “clever” enough to ignore late BQLs (replaced by zeros) and will not add a triangle after tlast (i.e., apply Pharsight’s unspeakable invention AUCall instead of AUClast). #2 will always lead to discrepancies to my results since I abandoned using scheduled sampling times in NCA decades ago.

❝ Well, life just isn't always optimal :-)

All too true.

BTW, another goody in Section 11.4.2

The regression lines, based upon at least four points during the terminal log-linear phase of the curve, used to estimate the terminal disposition rate constant (λ) should also be displayed.


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