Dr.ReproEndo said:They are two different exemptions from the same federal requirements and they buy different things.
All true, with one condition: that curve is for people who reached the dose on schedule. Anyone who slowed the ladder for tolerability is on a different, flatter curve, and comparing yourself with the published mean will make you feel like a non-responder when you are not.
I would rather be corrected than agreed with, if it comes to it.
DeniseRN_TPA said:Steady state is the thing most people miss.
This is exactly what I could not find anywhere else.
Dr.ReproEndo said:They are two different exemptions from the same federal requirements and they buy different things.
Filing a mild objection. Mild because I might be wrong; an objection because nobody has addressed the case that does not fit. The trial means are being read too generously in this thread. STEP populations were selected, supported, and titrated by protocol, and the real-world curves are consistently a few points worse. That difference is not noise, it is what happens when you remove the study infrastructure.
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Browse GL BiochemAdding the numbers, since they settle part of this. Two things anyone can check: a state licence number for a 503A, and an FDA outsourcing-facility registration for a 503B. Both are publicly searchable, and a pharmacy unwilling to give you either has answered the question.
Moderator note: the sourcing question belongs in the vendor section and has been split out. Report rather than reply if it drifts again.