Bioequivalence and Bioavailability Forum

"Meth" - apologies [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2013-04-22 22:03 (4811 d 16:16 ago) – Posting: # 10463
Views: 17,087

Hi again,

❝ Good guess. Not exactly meth (that was the story at the end of this post), but close. Remember the recent Two-Stage thread?

Jawohl; I apologise for that abbreviation - I actually meant meth█████ which I have seen have quite low intra-CVs in IR formulations. In the world of inhalation I also occasionally see meth used as acronym for methacholine. It is used to provoke artifical asthma attacks in volunteers. Wonderful stuff - crossover studies now and then have a lot of subjects who mysteriously don't feel like showing up for period 2

---

Edit: Your guess was exactly right. However, I blacked it out (not sure whether the sponsor wants to see it in public right now). Low CVs also for all MR formulations – unless you go for the first pAUC (not to speak about EMA’s invention pC_max,1).

Complete thread:

• Incurred sample reanalysis sarada06884 2013-04-09 12:22 
  • Incurred sample reanalysis Ohlbe 2013-04-09 14:09
    • Incurred sample reanalysis The Outlaw Torn 2013-04-10 08:40
      • Clopidogrel Ohlbe 2013-04-10 10:34
        • Clopidogrel The Outlaw Torn 2013-04-10 11:31
          • Lack of ISR / only 5% ISR in study with 656 samples Helmut 2013-04-22 17:01
            • Lack of ISR / only 5% ISR in study with 656 samples ElMaestro 2013-04-22 18:56
              • Lack of ISR / only 5% ISR in study with 656 samples Helmut 2013-04-22 19:35
                • "Meth" - apologiesElMaestro 2013-04-22 20:03
                  • "Meth" - apologies The Outlaw Torn 2013-04-23 08:27
                    • "Meth" - apologies ElMaestro 2013-04-23 14:29
                      • "ISR" - apologies The Outlaw Torn 2013-04-24 07:44
                        • Repeat use ElMaestro 2013-04-24 11:08
                          • Repeat use Ohlbe 2013-04-24 11:41
                            • Repeat use ElMaestro 2013-04-24 13:45
                        • "ISR" – resolved Helmut 2013-09-20 21:50
                          • "ISR" – resolved Dr_Dan 2013-09-22 16:56
            • Lack of ISR / only 5% ISR in study with 656 samples ElMaestro 2013-04-23 23:31
              • Some more stuff Helmut 2013-04-24 02:08
              • Lack of ISR / only 5% ISR in study with 656 samples nobody 2014-10-23 10:06