Bioequivalence and Bioavailability Forum

Helmut
★★★

Vienna, Austria,
2019-03-06 16:48
(2049 d 20:22 ago)

Posting: # 20000
Views: 5,242

Warning: BE in ThothPro [Software]

Dear all,

I just tested the BE module of the current release 4.3.0 of ThothPro™.
I haven’t tried higher-order crossover and replicate designs yet.

Parallel designs are not implemented.
α can only be set in steps of 0.01 (though one has to specify 0.1 and not 0.05 to get the 90% CI). Too bad if you want 0.0294.
Unfortunate: The default is 0.01. If overlooked, one is punished with a 99% CI. Pretty conservative.
Funny: It is possible to select 1.00…
The lower and upper limits have to be specified separately (and not Δ like in PHX/WNL). That’s prone to errors. Furthermore, limits can be selected only in steps of 1%. Bad luck for people in Russia wanting to pre-specify 75.00–133.33% for C_max.
Outcome of our 2×2×2 reference datasets:
- The small balanced datasets (A, B, D, E, F) passed.
- The small imbalanced dataset C (n=13) failed with an outcome slightly different from infamous Kinetica.
  I got PE 66.78%, 90% CI 44.94–99.24%
  (correct: 58.56%, 39.41–87.03%; Kinetica: 66.78%, 44.91–99.31%). Would be interesting which formula is implemented.
- The large datasets G (balanced n=1,000) and H (imbalanced n=717) did not give any result at all.
  By trial-and-error: The maximum sample size is 100 (nothing stated in the manual).

Hence, I cannot recommend to use the software for BE till its glitches are fixed.

—
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

nobody nothing 2019-03-06 18:11 (2049 d 18:58 ago) @ Helmut Posting: # 20001 Views: 4,477	Warning: BE in ThothPro Post reply
	alpha tester :-p — Kindest regards, nobody

Helmut
★★★

Vienna, Austria,
2019-03-11 14:08
(2044 d 23:01 ago)

@ nobody
Posting: # 20014
Views: 4,295

BE in ThothPro 4.3: alpha stage

Post reply

Hi nobody,

❝ alpha tester :-p

Seems so. Quote from an e-mail I received today:

Indeed we are with BE on alpha stage and we need to work hard to develop it towards full-featured software. It is true that only balanced data sets and cross-over design are allowed for this moment.

BTW, we find this statement on the website:

The software is safe, secure (e.g. has built-in a true Full Audit Trail), and complies with all pertinent EU and US regulations.

This “Full Audit Trail” is similar to Phoenix/WinNonlin’s “History”. In both softwares you can alter the data, perform a calculation, produce a more or less nice report, and at the end – if you don’t save the project-file – nothing is visible in this “Audit Trail”.
At least in PHX/WNL you can have a true audit trail investing some bucks in the Phoenix Knowledgebase Server (PKS).

—
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

nobody nothing 2019-03-11 16:03 (2044 d 21:07 ago) @ Helmut Posting: # 20015 Views: 4,302	BE in ThothPro 4.3: alpha stage Post reply
	Told you so. most-hated-but-most-often-used sentence. Will most likely not change in the future... — Kindest regards, nobody

mittyri ★★ Russia, 2019-03-07 00:44 (2049 d 12:26 ago) @ Helmut Posting: # 20004 Views: 4,484	devil in the details Post reply
	Dear Helmut, `...exactly the same formulas, exactly the same equations, exactly the same numerical results, just more efficient code...` well, something is not exact As usual, devil in the details (and extremums) — Kind regards, Mittyri

d_labes
★★★

Berlin, Germany,
2019-03-07 20:45
(2048 d 16:24 ago)

@ Helmut
Posting: # 20009
Views: 4,365

ThothPro - Pro = professional?

Post reply

Dear Helmut, dear All!

Since this is already version 4.3.something I wouldn't expect Helmut's results in testing this piece of software.

At least not since our release of the reference datasets and the Kinetica fiasco.*
It should be more mature IMHO.

And at least not since the company behind this ThothPro™ was already founded in 2014, 5 years ago! Whatever this is, ThothPro™. Whatever this means: "Our proprietary SeshatPro™ platform serves as a template for constructing software using a novel, more logical way or writing the code. Resulting solutions are orders of magnitude faster than the existing ones, and are easy to use due to their intuitive interfaces taking full advantage of consistently using menus expandable with the right click of a mouse. Our first software based on principles of the SeshatPro™ is TP4.3 for pharmacometric calculations and modeling."
Poland has not perished yet?
Proprietary software beating them all? Validated?

I myself doesn't understand at all. Any body out there to enlighten me?

Does it mean they have discovered the right mouse button? Or have they found the "philosopher's stone" to program all the tasks associated with BE studies, beginning from NCA up to all the necessary statistics for deciding bioequivalence?

Does anybody know someone which had used this software for real BE studies in the past up to now? If yes with which regulatory outcome?

Schütz H, Labes D, Fuglsang A. Reference Datasets for 2-Treatment, 2-Sequence, 2-Period Bioequivalence Studies. AAPS J. 2014;16(6):1292–7. doi:10.1208/s12248-014-9661-0. PMID 25212768. PMC Free Full text.

—
Regards,

Detlew

Warning: BE in ThothPro [Software]

Warning: BE in ThothPro

BE in ThothPro 4.3: alpha stage

BE in ThothPro 4.3: alpha stage

devil in the details

ThothPro - Pro = professional?