Bioequivalence and Bioavailability Forum • EMA: ABEL

EMA: ABEL [RSABE / ABEL]

posted by Clarc – Romania, 2013-10-28 11:04 (4216 d 22:02 ago) – Posting: # 11790
Views: 4,588

Dear Dr.S.Gunasakaran, Dear Helmut

Thanks for the replies, and for the advices.

❝ May I guess: Kinetica?

Yes, You may... and Yes unfortunately... it is Kinetica.

❝ Don’t forget two obstacles:

A sound justification that a wider difference in C_max is clinically irrelevant.
❝
A justification that the calculated intra-subject variability is a reliable estimate and that it is not the result of outliers.

Of course I will not forget about these...

Thanks again.

—
I'm always tryin' to do something new, tryin' to look like a beginner.
Meshell Ndegeocello

Widening Cmax in EU Clarc 2013-10-24 14:55 [RSABE / ABEL]
- Widening Cmax in EU drgunasakaran1 2013-10-24 15:43
- EMA: ABEL Helmut 2013-10-25 14:56
  - EMA: ABELClarc 2013-10-28 10:04