Emax and ED50: NLME [Software]

posted by Helmut Homepage – Vienna, Austria, 2015-12-29 18:46 (3328 d 23:35 ago) – Posting: # 15777
Views: 18,147

Hi G.C.,

❝ Please find below FDA guideline data for calculation ED50 and Emax using nonlinear mixed effect model (population model). Please let me know value matches with guideline or not.


These data smell of FDA’s 1995 (!) Guidance on topical corticosteroids, Table AIII.4… Software: P-Pharm (Simed, France). ED50 1.89 h, Emax –48.8 h. The software doesn’t exist any more, the developer went out of business, the FDA didn’t give any details (fitting algo, weighting, constraints, …). Do you really expect that anybody without a time-machine will be able to reproduce these numbers? Was the fitted line drawn by someone with shaky hands or did the software spit it out?

[image]


These nice bars are standard errors – not standard deviations, aka cheating with statistics. At 0.75 hours the mean is –17.7 and the SD 21.4. Agreed, the SE with 6.2 looks better. The CVs range from 60 – 250%. Did you look at the individual data?

BTW, addressing Simon here is not a splendid idea. He passes by about once a month in his spare time. I hope for him that he is enjoying a Christmas / New Year vacation. Why didn’t you register at Certara’s forum and upload something there – as Simon and I suggested – instead of posting a data-cemetery full of tabs nobody could copy/paste? Please read Eric Raymond’s essay How To Ask Questions The Smart Way.

I’m half tempted to close this thread.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Thread locked

Complete thread:

UA Flag
Activity
 Admin contact
23,376 posts in 4,912 threads, 1,666 registered users;
233 visitors (0 registered, 233 guests [including 12 identified bots]).
Forum time: 18:21 CET (Europe/Vienna)

The great tragedy of Science – the slaying
of a beautiful hypothesis by an ugly fact.    Thomas Henry Huxley

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5