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Hi everybody,
I was reading your disscusion and I would like from somebody to
explain what does this dosing interval really mean.
If i have a study single dose cross over comparative and the product
is modified release. Sampling is thru 72 hours and washout period is
7 days.
Am i going to drop the data from pk/stat analysis if subject vomits
thru 72 hour after dose or if subject vomits thru the hole study or I
will use 2* median Tmax as a boundary for that?
And I would be very happy if somebody could refer me to a good book,
article, or anything useful.... where emesis, diarrhea, saline
solution infusion and there impact on pk of drugs
is explained.
Thanx in advance,
lidija
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Hi Lidija,
For MR (ER or CR or EC) products dosing interval is generally 24 hrs.
You can exclude if vomitting occurs during dosing interval, because
we are not sure for MR products regarding the absorption length.
Hope this helps.
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