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Laura Carreiras ☆ Portugal, 2022-05-11 15:11 (881 d 00:13 ago) Posting: # 22969 Views: 2,468 |
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Dears, In a in a bioequivalence study with a full replicate design conducted in more than one group, how shall the group participants be separated/divided? For example, Initially we have 3 groups but because of some constraints the washouts for a few participants had to be extended. The participants will be added to the groups accordingly with the administration date of the first period (even if the other periods can have a different administration date) or the groups shall be formed accordingly with the date of administration of all the periods (for each group all the administration date of the 4 periods has to be the same)? I hope I was clear. Thank you for the help. Edit: Category changed; see also this post #1. [Helmut] |
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dshah ★★ India, 2022-05-12 13:46 (880 d 01:38 ago) @ Laura Carreiras Posting: # 22973 Views: 1,931 |
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Hello Laura! Generally fully replicate study will be useful for HVD or NTI. In both the condition, the Swt and Swr will play a role in BE acceptance (Particularly AUC). Assuming this- it is better to group according to date of administration of all periods. Regards, Divyen |
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mittyri ★★ Russia, 2022-05-15 00:30 (877 d 14:55 ago) @ Laura Carreiras Posting: # 22988 Views: 1,902 |
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Dear Laura, ❝ The participants will be added to the groups accordingly with the administration date of the first period (even if the other periods can have a different administration date) or the groups shall be formed accordingly with the date of administration of all the periods (for each group all the administration date of the 4 periods has to be the same)? I would use the groups with equal administration dates, so the periods are equal within the groups. It won't hurt (CIs won't significantly change) and does not raise the questions since you are following some internal logical rules (different period dates -> different groups). — Kind regards, Mittyri |
Ing. Helmut Schütz