Skip to main content
SpringerPlus

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)
Back to article page