Development of dosing guidelines for reaching selected target breath alcohol concentrations

Objective: This study evaluated gender-specific ethanol dosing protocols th at were designed to result in one of two peak breath alcohol concentrations (BrACs)-0.07 or 0.10 g/2101. Inter- and intrasubject variability in BrAC w ere assessed and several possible methods for reducing variability in BrAC were evaluated. Method: Subjects (16 women, 16 men, ages 21-30 years) were studied after low (women 0.49 g/kg, men 0.53 g/kg consumed over 10 minutes) and high (women 0.81 g/kg, men 0.89 g/kg consumed over 20 minutes) ethanol doses, consumed following a 4-hour fast. All subjects were regular drinker s. Results: Mean (+/-SD) peak BrACs actually achieved were 0.069 +/- 0.011 g/2101 after the low dose, and 0.105 +/- 0.014 g/2101 after the high dose. Mean values for peak BrAC, time to peak BrAC and area under the curve were not statistically significantly different between genders at either dose. B rACs varied by as much as twofold between subjects after equivalent gender and body weight adjusted doses. There was some reproducibility of ethanol p harmacokinetic parameters over dose and time in men, but not in women. Conc lusions: The doses used resulted in equivalent mean ethanol exposures for w omen and men at each dose, with mean peak BrACs that closely approached the targets, but there was substantial inter- and intrasubject variability in ethanol pharmacokinetics.