Bioequivalence and Bioavailability Forum • Clarification on model statement in EMEA submission

Clarification on model statement in EMEA submission [RSABE / ABEL]

posted by RK – India, 2013-10-08 15:39 (4236 d 09:11 ago) – Posting: # 11623
Views: 6,354

Hi all,

I would like to clarify two things from below given program for reference replicate design,

what is the use of keeping G matrix in the model. if we ignore, wether it will affect the final results.
if the study is for EMEA submission, random effect will not be considered, but where as in the below given program treatment effect given as both fixed and random. what to do???

can we considered this as Subject within TRT as random effect for EMEA?

Calculation of unscaled 90% bioequivalence confidence intervals:

PROC MIXED

data=pk;

CLASSES SEQ SUBJ PER TRT;

MODEL LAUCT = SEQ PER TRT/ DDFM=SATTERTH;

RANDOM TRT/TYPE=FA0(2) SUB=SUBJ G;

REPEATED/GRP=TRT SUB=SUJ;

B ESTIMATE 'T vs. R' TRT 1 -1/CL ALPHA=0.1;

run;

Regards
RK.

Complete thread:

Clarification on model statement in EMEA submissionRK 2013-10-08 13:39
- EMA: all effects fixed Helmut 2013-10-08 14:08
  - EMA: all effects fixed RK 2013-10-09 06:32
    - EMA: all effects fixed - Method A! d_labes 2013-10-09 08:30
    - EMA: Method C “incompatible with CHMP GL” Helmut 2013-10-09 14:50
      - EMA: Method C “incompatible with CHMP GL” RK 2013-10-10 06:01