Bioequivalence and Bioavailability Forum

Hi All,

kindly provide your opinion.

1. In case of HVD with long half life drugs, can we go head with truncated design,

as per Amiodarone OGD guidlines showing that
For drugs demonstrating high intrasubject variability in distribution and/or clearance, AUC truncation should not be used.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM238049.pdf

2. In case of truncated study how can we handle the missing samples in statistical calculations.

Eg.
study is truncated AUC0-72.

volunteer is in-house up to 24.00 hours.
36.00, 48.00, 72.00 hours are the ambulatory samples.

if a subject not reported to facility at 48.00, 72.00 hours sampling.

how can we use those kind of subjects pK in statistics calculations.

can we include or exclude those subjects.

Thanks.