Bioequivalence and Bioavailability Forum

In-vitro equivalence [General Sta­tis­tics]

posted by martin  – Austria, 2012-05-19 12:28 (5140 d 16:31 ago) – Posting: # 8589
Views: 6,107

Dear ElMaestro!

We were asked by a regulator to examine a random sample of k>25 lots produced (including also already formally "released" lots) each evaluated with at least 3 replicates. The information that I have is that we have to show (whatever that means) that the lots are "comparable" to the reference lot (i.e. kind of standard) and superior to the negative control lot (also a kind of standard without biological activity).

I would be really glad to get some ideas and suggestions!

best regards

martin

PS.: I do not like the word comparable: apple and oranges

PPS.: it's a biologic - QbD

Complete thread:

• In-vitro equivalence martin 2012-05-17 15:10 
  • In-vitro equivalence ElMaestro 2012-05-19 01:35
    • In-vitro equivalencemartin 2012-05-19 10:28
      • In-vitro equivalence ElMaestro 2012-05-19 13:55
        • In-vitro equivalence Alex 2012-05-22 11:10
          • In-vitro equivalence ElMaestro 2012-05-22 14:08
            • In-vitro equivalence martin 2012-05-22 17:00
              • In-vitro equivalence ElMaestro 2012-05-22 18:36