Back to the Top
Dear all,
please clarify my elementary doubts.
If we do a bioequivalence study of an anti-cancer drug in 6 parts in
24 cancer patients(6x4),in what way it will affect the statitical
aspect of the study.Since it is done in patients, we can't expect all
the patients to be dosed on the same time.
also we cant expect to get all patients from one single hospital or
site.definitely we have to go for multiple sites.
How these details should be incorporated in our protocol?
Should we mention 'multicentric' in the title of the bioequivalence
study?
Apart from period,sequence,subject nested within the sequence,what
other effects will be included for statistics?
Regards,
Muhiyideen
Back to the Top
Dear Mr.Muhiyideen,
I think, you have to go for 'Group Effect' apart from other common
effects, which affect the outcome of the study.
And you can also mention the study as 'Multicentric', if it is planned
to carry out in different sites.
Hope the experts will clarify much on this.
Habeeb
Want to post a follow-up message on this topic?
If this link does not work with your browser send a follow-up message to PharmPK@boomer.org with "Statistical aspect of anti-cancer BE study" as the subject | Support PharmPK by using the |
Copyright 1995-2011 David W. A. Bourne (david@boomer.org)