Fully Replicate Study [Study As­sess­ment]

posted by NK – India, 2021-04-26 11:46 (1118 d 04:38 ago) – Posting: # 22323
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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: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


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

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