Bioequivalence and Bioavailability Forum

post additional studies [PK / PD]

posted by nobody – 2015-01-13 19:28 (4176 d 16:50 ago) – Posting: # 14285
Views: 11,522

Here you can find at least some numbers for Ctrough in Tab 1 and 2

http://www.chinaphar.com/1671-4083/25/390.pdf

...although its only for 200mg, it's somewhat higher than LLOQ (the reason why I posted in the Bioanalytics section), but exhibits some variability. Most studies evaluate Ctrough for some days (to "evaluate" steady-state), but metrics for BE rely on only ONE concentration, hmmmm....





(And apparently t1/2 is 7 h for the ER formulation )

Complete thread:

• Lottery or science? nobody 2015-01-13 10:21 
  • Lottery or science? ElMaestro 2015-01-13 10:38
    • Lottery or science? nobody 2015-01-13 10:45
      • Lottery or science? ElMaestro 2015-01-13 11:05
        • Lottery or science? nobody 2015-01-13 11:23
          • Lottery: maybe. Science: no. Helmut 2015-01-13 13:50
            • Lottery: maybe. Science: occasionally ElMaestro 2015-01-13 16:45
              • Lottery: maybe. Science: occasionally nobody 2015-01-13 17:16
            • Lottery: maybe. Science: no. nobody 2015-01-13 17:12
              • post additional studies ElMaestro 2015-01-13 17:46
                • post additional studiesnobody 2015-01-13 18:28
              • Historic abstract of Cmin in BE Helmut 2015-01-14 01:42
                • Historic abstract of Cmin in BE nobody 2015-01-14 08:42