Validation of FDA's RSABE on NTIDs [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2017-08-30 17:04 (2216 d 08:27 ago) – Posting: # 17757
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Hi Yong,

❝ I am eagerly hope you publish such reference datasets, like those two papers published in AAPS J in 2015 for two way crossover and parallel design.

We are working on a paper for the EMA’s ABEL. ;-) We will also provide an R-package. It is still a work in progress. Its current state on GitHub. In the inst/extdata folder our reference data sets. NTIDs are DS02.csv (TRR|RTR|RRT), DS05.csv (TRRT|RTTR), and DS10.csv (TRR|RTT). Sorry, none with TRTR|RTRT…

❝ I now use WNL PHX and SAS and/or Excel to analysis NTID. Excel is used just for SigmaWR and SigmaWR/SigmaWT and it's upper llevel of %CI, not for ABE or RSABE in such case.

Our results with replicateBE and the latest template for PHX/WNL:
DS05.csv: swT∕swR 1.0184, upper CL of σwTσwR 1.4344.
DS10.csv: swT∕swR 1.2566, upper CL of σwTσwR 2.3300.

❝ BTW, I have developed a program in VBA in Excel for BE analysis, it has passed all 2*2*2 and 2‖2 reference datasets you provided. This program is not intended for commercialization, but will be published for free use in future. Like PKSolver and DDSolver which have been published.


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