Bioequivalence and Bioavailability Forum

Bear: feature requests [🇷 for BE/BA]

posted by Helmut  – Vienna, Austria, 2010-12-08 16:48 (5666 d 16:28 ago) – Posting: # 6273
Views: 17,352

Dear bears!

Some suggestions for your To-Do list.

• NCAplots.pdf
  • In the subjects' log-plots an overlay of the fitted lambda_z lines (IMHO good practice and mandatory in Canada).
    
  • Split the mean plot: one showing the means (without SD) and mean plots of formulations with SD. Especially if the study was 'well designed' (enough data points in the area of C_max the mean plot right now is quite crowded with all the whiskers.
• NCA_PK.txt
  
  • I would add a section containing the means/SD for each formulation (by time point) - now it's not possible to cross-check with the plots.
    
  • Think about geometric means/SD; some (European) regulators prefer a plot of geometric rather arithmetic means.
    Hint: SD_geom=exp(sqrt(1/(n-1) × Sum((ln(x)-ln(x_geom))²)) - hope, I got all the parentheses right.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


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Complete thread:

• Bear: feature requestsHelmut 2010-12-08 15:48 
  • Bear: feature requests yjlee168 2010-12-08 18:49
    • Bear: feature requests Helmut 2010-12-08 19:48
    • Bear: feature requests d_labes 2010-12-09 08:48
      • Bear: feature requests Helmut 2010-12-09 14:20
        • Bear: feature requests yjlee168 2010-12-09 20:24
      • Bear: feature requests yjlee168 2010-12-09 19:57
        • Bear: feature requests Aceto81 2010-12-13 10:26
          • Bear: feature requests yjlee168 2010-12-13 13:29
  • Geometric mean? re: Bear: feature requests yjlee168 2013-03-27 13:21
    • Geometric mean in plots Helmut 2013-03-27 14:18
      • Geometric mean in plots yjlee168 2013-03-27 21:16