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mathews ● 2008-01-19 12:32 (6734 d 21:06 ago) Posting: # 1532 Views: 3,939 |
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Hi All,  One doubt regarding the analysis of a BE study. In a 2x4 replicated BE study with 24 subject. Finally only 22 subjects are completed all period and two of them are completed only first two period. Is there any problem if I analyse the study using the data of that 22 subjects, who completed all periods?..... Is it required to specify in the protocol that the statistical analysis will be done only using the data from subjects that complete all periods?...... regards Matz |
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Helmut ★★★   Vienna, Austria, 2008-01-21 14:47 (6732 d 18:51 ago) @ mathews Posting: # 1535 Views: 3,250 |
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Dear Matz! ❝ One doubt regarding the analysis of a BE study. In a 2x4 replicated BE study with 24 subject. Finally only 22 subjects are completed all period and two of them are completed only first two period. So in this two subjects you have no information from a third treatment which may be used in a mixed-model approach (SAS PROC MIXED). Therefore the results of PROC MIXED (n=24) will be identical to PROC GLM (n=22). ❝ Is there any problem if I analyse the study using the data of that 22 subjects, who completed all periods?..... No (see above). ❝ Is it required to specify in the protocol that the statistical analysis will be done only using the data from subjects that complete all periods?...... You should specify the method in the protocol. Quoting Senn (2002): “In the context of drug development […] it will be important to specify beforehand which approach (fixed or random) will be used.” For the entire quote and the reference see this post.— Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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mathews ● 2008-01-23 06:12 (6731 d 03:26 ago) @ Helmut Posting: # 1541 Views: 3,120 |
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Dear HS! Thank you so much for your reply. Could you please explain about the fixed model and random model. regards Matz. |
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drdds ● 2008-01-23 07:53 (6731 d 01:45 ago) @ mathews Posting: # 1543 Views: 3,094 |
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Dear, You need to analyse or work on 22 subjects only. Once the subject has completed both periods, then only you can take consider that volunteer for PK analysis. Regards, Dr.dds |
Ing. Helmut Schütz