Bioequivalence and Bioavailability Forum • Regulatory french replicates

Regulatory french replicates [Regulatives / Guidelines]

posted by d_labes – Berlin, Germany, 2009-09-30 18:48 (6117 d 11:44 ago) – Posting: # 4279
Views: 5,105

Dear Yung-jin,

❝ Guess many other colleagues are looking for the answers of your QUESTION now. I don't know if I can really help here. But allow me to try first. :-)

Thanx.

❝ To calculate intra-individual variabilities and means seems not a problem for the guy like you.

Of course not :-P

. One part of the output of the Proc MIXED code contains the intra-subject variabilities for Test and Reference and the between-subject variability also. They have therefore what they request.
But it seems they do not belief in the results of the REML estimates from that Proc MIXED
That's where my confusion comes from. And means make no sense within the category if intra-subject variance.

❝ Or see Hauschke D., et al., "Bioequivalence Studies in Drug Development - Methods and Applications", 2007, pp. 258-9.

Cannot find anything about intra-subject variabilities on that pages.

❝ [...] [BTW, where to get it? Is this drug2-replicate program (SAS macros) freely available?]

Sorry. But its the property of the company I am working in.

—
Regards,

Detlew

Complete thread:

Regulatory french replicates d_labes 2009-09-30 10:55
- Regulatory french replicates yjlee168 2009-09-30 13:39
  - Regulatory french replicatesd_labes 2009-09-30 16:48
- Regulatory french replicates ElMaestro 2009-09-30 14:11
  - MoM or Dad d_labes 2009-10-01 08:45
    - I am guessing, too! ElMaestro 2009-10-01 11:40
      - Old socks d_labes 2009-10-01 12:43