Bioequivalence and Bioavailability Forum

Dear All,

We did BE study (both fasting and fed) for ER formulation of a drug (HVD), with fully replicated design (RTRT/TRTR) for USFDA. The protocol says, plasma samples from subjects who complete all the four periods will be analyzed and will be included for PK and statistical analysis.

Where we observed following:

• Subject A - had BLQ (Below limit of Quantification) for all the time points for one of Test treatment and
  
• Subject B - had BLQ for all the time points in one of Reference treatment.
  
• Subject C – had very low T/R Ratio (outlier was not mentioned in the protocol)

Can we include Subject A & B for statistical analysis (protocol not specified about handling subject with three periods data. (ie. one T & two R and one R & Two T).

To handle this kind of situation in future, Can we mention in the protocol to exclude the subject (outlier) with above scenario.

Thanks in advance

Regards
NK

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Edit: Category changed; see also this post #1. [Helmut]