Bioequivalence and Bioavailability Forum

Dose based on m² [General Statistics]

posted by VK – Russia, 2013-07-17 18:17 (4728 d 17:12 ago) – Posting: # 11000
Views: 11,380

Dear Dr_Dan,

Thank you for the prompt reply. Please let me comment below:

❝ What do you mean by "We did regular calculations"?

We calculated PK parameters (Cmax, AUClast and Cmax/AUClast), correspodning 90% CIs and ANOVA (as required in Russia) for 100% of patients.

❝ If you had choosen

❝ 70% received 4x25mg

❝ 30% received either 3x25mg or 5x25mg

❝ Then 100% of the subjects could be evaluated.

This is our case. To shed more light on the design - 70% receieved 4*500mg, while 30% received either 3*500mg or 5*500 mg. Hence the only strength was 500, while the doses were different.

So the regulatory body experts tell us that we should use 70% for the calculation because the received one dose. That is why I looking for some kind of GL/textbook I could refer our experts.

Cheers,

VK

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 m²VK 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

Dose based on m² [General Sta­tis­tics]

Complete thread:

Dose based on m² [General Statistics]