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satishkoya ☆ 2009-04-06 08:36 (6280 d 07:40 ago) Posting: # 3476 Views: 4,498 |
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dear all, can anybody explain on following, suppose if i observe statistical significance for period,sequence, treatment effect, how these effects influence the final outcome results and bioequivalence. based on these effects is there any specifications from regulatory guidelines. and let me know any one example for rejection of study based on above mentioned parameters regards, k.satish |
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JPL ☆ Vienna, 2009-04-06 12:12 (6280 d 04:04 ago) @ satishkoya Posting: # 3480 Views: 3,733 |
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Dear satish, just keep in mind, that you want to have a effect from your treatment not influenced by any other effect. Thus, period of sequence effects are mixing up your treatment effect and you cannot claim that the observed difference comes from the treatment alone. The exact meaning of period and sequence effects depend on the study design and the treatments, the regulatory implications on the relevant guidelines you have to adhere to. Regards, JPL |
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Helmut ★★★   Vienna, Austria, 2009-04-06 14:59 (6280 d 01:17 ago) @ JPL Posting: # 3483 Views: 3,717 |
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Dear JPL! ❝ just keep in mind [...] period [...] effects are mixing up your treatment ❝ effect and you cannot claim that the observed difference comes from the ❝ treatment alone. Period effects do not influence the treatment effect in a cross-over study. Just give it a try: take any data set and multiply responses of the second period by ten - BE (point estimate, CI) will be exactly the same! — 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 |
Ing. Helmut Schütz