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Table 3 The distribution of the most frequent adverse events related to the BE study designs

From: Pooled bioequivalence study database from Turkey: characterization of adverse events and determination of split points based on Gini Index as a promising method

  BE study periods Before dosing/washouta Total
I II III IV
Adverse events (total) 870 758 6 1 7 1642
Adverse events types
 Headache 262 260 5 527
 Somnolence 130 129 259
 Nausea 100 93 1 1 195
 Dizziness 61 55 116
 Vomiting 34 19 1 54
 Other adverse events 283 202 6 491
  1. aElimination process of drug from the volunteer to ensure that drug concentrations are below the lower limit of bioanalytical quantification in all volunteers at the beginning of the second period (Cathcart et al. 2010)