Bioequivalence and Bioavailability Forum

It's breakfast time [Design Issues]

posted by ElMaestro  – Denmark, 2010-08-25 17:14 (5767 d 04:25 ago) – Posting: # 5832
Views: 6,628

Hi Pavidus and Andrew,

I concur.
In fact, I'd love to see the guideline logic applied to Regenon. European SPCs say that it should be taken a half or whole hour after a meal, of course without really specifying what the meal is like.

So, we'd basically have to go for a fed study w/ high-fat meals for a tablet intended (4.1) for weight loss in conjunction with diet.

Complete thread:

• Timing of high-fat breakfast Dr Andrew Leary 2010-08-24 12:13 [Design Issues] 
  • It's breakfast time d_labes 2010-08-24 13:00
    • Yummz ElMaestro 2010-08-24 15:09
      • Yummz Dr Andrew Leary 2010-08-24 16:22
      • Reading matters Helmut 2010-08-24 16:34
    • It's breakfast time Dr Andrew Leary 2010-08-24 16:20
      • It's breakfast time Pavidus 2010-08-25 14:11
        • It's breakfast time Dr Andrew Leary 2010-08-25 14:52
          • It's breakfast timeElMaestro 2010-08-25 15:14
          • It's breakfast time Ohlbe 2010-08-25 16:07
            • It's breakfast time Dr Andrew Leary 2010-08-25 16:15
        • It's breakfast time Dr_Dan 2010-08-25 15:33
          • It's breakfast time Dr_Dan 2010-08-25 15:49
            • It's breakfast time Helmut 2010-08-25 16:22
              • It's breakfast time Pavidus 2010-08-26 10:02