Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2017-11-22 17:33 CET (UTC+1h)
 

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

posted by Ramesh Ramalingam - India, 2017-09-05 07:35  - Posting: # 17776
Views: 935

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:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum | Admin contact
17,494 Posts in 3,746 Threads, 1,086 registered users;
26 users online (0 registered, 26 guests).

The whole purpose of education is
to turn mirrors into windows.    Sydney J. Harris

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
XHTML/CSS RSS Feed