Bioequivalence and Bioavailability Forum • dropouts in replicate studies

dropouts in replicate studies [Regulatives / Guidelines]

posted by dshah – India/ United Kingdom, 2021-09-23 19:28 (33 d 09:13 ago) – Posting: # 22591
Views: 463

Dear Loky do:
It is always better to ask the volunteer to complete the other period. Even if they miss one period or two period, the data can be useful in following ways:

For fully replicate study- Missing a test period--> Data can be useful for Swr calculation, safety evaluation and also average BE.
Fully replicate study- missing a reference period--> Useful for Swt, safety and ABE
Fully replicate study--> Missing a test and reference period--> useful for ABE
Partial replicate study-> missing a test period--> useful for Swr
Partial replicate study--> missing a reference period--> useful for ABE.

Regards,
Dshah

Complete thread:

dropouts in replicate studies Loky do 2021-09-23 14:54 [Regulatives / Guidelines]
- dropouts in replicate studiesdshah 2021-09-23 19:28
- The EMA’s ‘Data set I’ is incomplete Helmut 2021-09-24 11:36
  - The EMA’s ‘Data set I’ is incomplete Loky do 2021-09-25 22:01