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Dear all,
In a 28 days toxicity study, shift in Tmax was observed in day 14
(2.5hrs) and day 28 (3.0hrs) as compared to day 1 (2.hrs). i would
like to know the possibilities of this trend?
Regards,
Rahul Vats
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Dear Rahul,
There is a need for more clarification regarding design features in
order to get a reasonable explanation. For instance, was the sampling
times the same within the three examination periods?
Regards,
Dimiter Terziivanov, MD,PhD,DSc,
Professor and Head, Clinic of Clinical Pharmacology and
Pharmacokinetics,
Univ Hosp "St. Ivan Rilski", 15 Acad. Ivan Geshov st, 1431 Sofia,
Bulgaria
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Are they estimated or measured
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Dear Rahul,
This cannot be claimed as to be shift in Tmax, keeping different
variables into consideration, such as species, sampling type (sparse/
serial), sampling time points, number of blood samples collected at
each time point (n), variation in dosing times across 28 days etc.
These variables do sometimes contribute to different Tmax across days
but within statistical acceptance.
I hope this helps.
Thanks,
Dr Pradeep Sharma,
Senior Research Scientist
Metabolism and Pharmacokinetics (MAP
Ranbaxy Research Laboratories
Gurgaon
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