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

posted by Helmut Homepage – Vienna, Austria, 2017-08-30 17:04 (2402 d 07:31 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.


Great!

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