Bioequivalence and Bioavailability Forum

Dear All

Reading about nivolumab, in the EPAR, there is a confusing information regarding the half life, im wondering if you dont mind to use your expertise to answer this question,
in the single dose pk study (with full pk sampling ) the half life was reported in 17 days, while in the multiple dose study (with sparse sampling) the half life was reported in 26 days, How could it be possible? How would you calculate the steady state in this situation?

I quote the exact word of the EPAR

"the mean terminal elimination half-life of nivolumab ranged between 17 and 27.5 days following single dose (study MDX1106-01) and Q2W administration (MDX1106-03) across the range of 0.1 to 10 mg/kg dose."

Thanks in advance for your time and dedication answering it

Best Regards

Javier

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Edit: EPAR linked and category changed; see also this post #1. [Helmut]