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InterOccasion in Population PK


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#1 raghava choudary

raghava choudary

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Posted 01 June 2016 - 05:30 AM

Hi all,

 

I am not clear with the definition or probably i dont know the definition of inter-occasion in population pk.

 

Does it mean, The same subject dosed at different occasions ?

 

Or

 

Can we consider each cohort administered different doses as an occasion ? There are typically 6- 8 cohorts in phase I studies, can we consider each cohort as different occasion?

 

Or

 

What does it actually mean ??

 

Please clarify ,

 

Thanks in advance,

 

 

RC

 

 



#2 smouksassi1

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Posted 01 June 2016 - 08:16 PM

occasion means that within the same subject you have sampling on multiple occasions/periods/ cycle of treatment.

 

all depends on the trail desgin if in your trial you dose the patient with say dose 1 then do a washoupt and dose another time with dose 2 etc. this second dose can be considered an occasion and then random fluctuation of the pk parameters can happen between occasion.

 

 

The period on which to define occasion is not that clear cut some consider every day as a separate occasion, others every dose others every cycle of treatment  , or everyweek etc.

 

There is a way also to have a flexible time based function (pulse/surge) that would let the data tell the model what period constitute an occasion.






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