necessity of retention samples for pilot BE study [Regulatives / Guidelines]

posted by nobody – 2019-11-26 09:11  – Posting: # 20872
Views: 369

» My angle on this was related. FDA recently issued a PSG for Beclo/Calcipotriol introducing the need for a pilot trial.

This is this occult skin bleaching (vasocontrictor) test, here you don't "ship" any samples at all.

Ladies, these backup samples are for reproducing results in case the primary analysis is fishy. And to stop labs from making up studies and results completely (with mixed results on this part). I would keep this in mind when planning a trial.

If you are in doubt, start a controlled correspondence with the-one-not-to-be-named (aka USA-FDA-Trump-whatever...)

Kindest regards, nobody

Complete thread:

Activity
 Admin contact
20,258 posts in 4,264 threads, 1,400 registered users;
online 11 (0 registered, 11 guests [including 10 identified bots]).
Forum time (Europe/Vienna): 02:39 UTC

Science is simply common sense at its best that is,
rigidly accurate in observation, and
merciless to fallacy in logic.    Thomas Henry Huxley

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