Bioequivalence and Bioavailability Forum

Different doses or strenghts? [General Sta­tis­tics]

posted by luvblooms  – India, 2013-07-18 08:42 (4719 d 15:53 ago) – Posting: # 11013
Views: 11,263

Dear Vk and Others

Good morning!!

Just a thought!!

why cant we use all the volunteers data and add the different dose based on volunteers BSA while calculating the the PK parameters (While doing NCA in Model → Dosing Regimen)?

We have done same in Capacetabiene for US and ANVISA submission and never got a query.

I may be wrong but this idea is worth pursuing!

Check how comfortable your data looks like with this method!!

Complete thread:

• Dose based on m² VK 2013-07-17 10:35 
  • Dose based on m² Dr_Dan 2013-07-17 11:09
    • Dose based on m² VK 2013-07-17 16:17
  • Different doses or strenghts? Helmut 2013-07-17 12:18
    • Different doses or strenghts? VK 2013-07-17 16:31
      • No problem with same strength but different doses Helmut 2013-07-17 23:17
      • Different doses or strenghts?luvblooms 2013-07-18 06:42
        • Different doses or strenghts? VK 2013-07-18 15:28
          • Different doses or strenghts? kumarnaidu 2013-11-21 14:00
            • Different doses or strenghts? Dr_Dan 2013-11-21 15:23
              • Different doses or strenghts? kumarnaidu 2013-11-22 05:34