yoyo87 ☆ Egypt, 2020-11-22 11:06 (1223 d 04:15 ago) Posting: # 22074 Views: 1,723 |
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hi, every one kindly i need your help to know the accepted deviation in time in ambulatory samples (24, 36, 48 and 72 hr) in bioequivalence studies?? example 6 hours deviation is accepted or not?? |
Helmut ★★★ Vienna, Austria, 2020-11-23 13:18 (1222 d 02:03 ago) @ yoyo87 Posting: # 22080 Views: 1,405 |
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Hi yoyo87, ❝ […] accepted deviation in time in ambulatory samples (24, 36, 48 and 72 hr) in bioequivalence studies?? example 6 hours deviation is accepted or not?? See also this recent thread. Well, six hours are extreme. I would even collect and analyze a 78 hr sample. Say, it was after the test-treatment and the reference was fine. If you don’t, you end up in your AUC0–tlast comparison with AUC0–48/AUC0–72, which is an apples-and-oranges comparison (negatively biased). If you do, you end up with AUC0–78/AUC0–72, which is positively biased. Two options (have to be stated in the protocol):
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