TS.xpt for bioequivalence study [Regulatives / Guidelines]

posted by mwagh – India, 2016-12-16 12:07 (2982 d 23:21 ago) – Posting: # 16848
Views: 3,990

Hi,

For a bioequivalence study, while creating the TS.xpt which approach should be followed
  1. Assign the drugname value to TRT variable and Keep COMPTRT blank.
  2. Assign the same drug name value to both TRT and COMPTRT variable.

Or is there any other suggested option?

Thanks,

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