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

posted by Ramesh Ramalingam - India, 2017-09-05 07:35  - Posting: # 17776
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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

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