RSABE/TSD-combo [Two-Stage / GS Designs]

posted by Helmut Homepage – Vienna, Austria, 2015-01-22 13:37 (3353 d 12:10 ago) – Posting: # 14311
Views: 5,212

Dear Madam,

why are you shouting at us?

❝ For Canadian submission, can we consider the Fully replicated crossover design with two-stage sequential approach for BE study?


ElMaestro correctly wrote above that no method is published yet. Note that currently HC does not accept refe­rence-scaling. In June 2014 the “Scientific Advisory Committee on Pharmaceutical Sciences and Cli­nical Pharmacology” recommended FDA’s method for implementation but is considering other approaches as well. Let’s see.
If you want to explore RSABE in a TSD with current hard-/software finding and validating an adjusted α would take ~six years. If you believe in Moore’s law (processing power doubles every 18–24 months) and you buy always the fastest available machine it would still take ~1½ years to get a result. Unless you find someone who is able to write some fancy C- or FORTRAN-code for a massive parallel super­computer (which will cost you a fortune) I don’t see a realistic way out.

If you want to run a fully replicate design for conventional ABE (no scaling) IMHO that should be doable. Start your own simulations.

❝ and how TPD will look at this?


With great interest. Report back their response.

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

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
82 visitors (0 registered, 82 guests [including 8 identified bots]).
Forum time: 01:48 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

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