Bioequivalence and Bioavailability Forum

Dear All,

Can anyone please suggest the appropriate study design for the bisphosphonates compounds. e.g. risedronate.

As I found some information regarding multiphasic half life of the same as below:

'Once risedronate is absorbed, the serum concentration-time profile is multi-phasic with an initial half-life of about 1.5 hours and a terminal exponential half-life of 480 hours. Although the elimination rate of bisphosphonates from human bone is unknown, the 480 hour half-life is hypothesized to represent the dissociation of risedronate from the surface of bone.' Ref.

as this is DR tablet showing high intra and inter subject variability can we truncate the study? as FDA suggest:
For drugs demonstrating high intrasubject variability in distribution and/or clearance, AUC truncation should not be used.

looking forward for appropriate answer.

thanks...