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Yura ★ Belarus, 2016-02-16 12:13 (3325 d 03:37 ago) Posting: # 15994 Views: 7,945 |
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Hi How to calculate the bioequivalence with the departure of the volunteer:
Kind regards Yura Edit: Category changed. [Helmut] |
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Dr_Dan ★★ Germany, 2016-02-16 15:12 (3325 d 00:38 ago) @ Yura Posting: # 15997 Views: 6,638 |
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Dear Yura Ideally, all treated subjects should be included in the statistical analysis. However, subjects in a crossover trial who do not provide evaluable data for both of the test and reference products (or who fail to provide evaluable data for the single period in a parallel group trial) should not be included. In principle any reason for exclusion of a subject from statistical evaluation is valid provided it is specified in the protocol and the decision to exclude is made before bioanalysis. Exclusion of data cannot be accepted on the basis of statistical analysis or for pharmacokinetic reasons alone, because it is impossible to distinguish the formulation effects from other effects influencing the pharmacokinetics. I hope this helps. Kind regards Dr_Dan — Kind regards and have a nice day Dr_Dan |
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Helmut ★★★   Vienna, Austria, 2016-02-16 15:19 (3325 d 00:31 ago) @ Dr_Dan Posting: # 15998 Views: 6,704 |
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Hi Dan, the forum’s jury is still out and we are awaiting its verdict how to deal with the partial replicate design (RRT | RTR | TRR). If a subject drops out after the second period in the sequence RRT I (!) would still include him / her in the estimation of CVwR. More data = better estimate. — 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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Dr_Dan ★★ Germany, 2016-02-16 16:59 (3324 d 22:51 ago) @ Helmut Posting: # 15999 Views: 6,699 |
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Hi Helmut you are nitpicking but absolut right. In my reply I referred to a general two-way crossover design. LG Dan — Kind regards and have a nice day Dr_Dan |
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d_labes ★★★ Berlin, Germany, 2016-02-23 09:40 (3318 d 06:10 ago) @ Helmut Posting: # 16019 Views: 6,353 |
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Dear Helmut, ❝ the forum’s jury is still out and we are awaiting its verdict how to deal with the partial replicate design (RRT | RTR | TRR). If a subject drops out after the second period in the sequence RRT ❝ I (!) would still include him / her in the estimation of CVwR. More data = better estimate. Me too. The SAS code of the FDA progesterone guidance forces this also: no missing in the calculation of the intra-subject contrast R-R. But this requires that drop-outs are not considered as protocol deviation / violation in the study protocol. — Regards, Detlew |
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Yura ★ Belarus, 2016-03-04 08:47 (3308 d 07:03 ago) @ Dr_Dan Posting: # 16047 Views: 5,913 |
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Thanks for the answer Dr_Dan Kind regards Yura |
Ing. Helmut Schütz