dropouts in replicate studies [Regulatives / Guidelines]

posted by dshah  – India, 2021-09-23 21:28 (1215 d 18:50 ago) – Posting: # 22591
Views: 2,794

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

Regards,
Dshah

Complete thread:

UA Flag
Activity
 Admin contact
23,363 posts in 4,906 threads, 1,677 registered users;
162 visitors (0 registered, 162 guests [including 8 identified bots]).
Forum time: 15:19 CET (Europe/Vienna)

The combination of some data and an aching desire
for an answer does not ensure that a reasonable answer
can be extracted from a given body of data.    John W. Tukey

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5