Bioequivalence and Bioavailability Forum • subject inclusion criteria in PK and stat and BE conclusion

subject inclusion criteria in PK and stat and BE conclusion [Regulatives / Guidelines]

posted by Ramesh Ramalingam – India, 2017-09-05 09:35 (2422 d 08:32 ago) – Posting: # 17776
Views: 7,492

Dear All,

I have more doubt on subject inclusion criteria for pharmacokinetic and statistical analysis in fully replicate (Including NTI drugs) and partial replicate design BE studies. could you please suggest the subject inclusion criteria for PK and stat analysis (including who's data can be considered for BE)? Also, How many treatment periods subject should be completed in the study?

Regards,
Ramesh Ramalingam

Complete thread:

subject inclusion criteria in PK and stat and BE conclusionRamesh Ramalingam 2017-09-05 07:35
- subject inclusion criteria in PK and stat and BE conclusion ElMaestro 2017-09-05 08:26
  - subject inclusion criteria in PK and stat and BE conclusion Ramesh Ramalingam 2017-09-05 09:17
    - subject inclusion criteria in PK and stat and BE conclusion ElMaestro 2017-09-05 09:20
      - subject inclusion criteria in PK and stat and BE conclusion Ramesh Ramalingam 2017-09-05 09:22
        
        subject inclusion criteria in PK and stat and BE conclusion ElMaestro 2017-09-05 10:16
    - At least twice R or twice T for sWR and sWT yicaoting 2017-09-05 15:23