D. Concordet et Pl. Toutain, THE WITHDRAWAL TIME-ESTIMATION OF VETERINARY DRUGS REVISITED, Journal of veterinary pharmacology and therapeutics, 20(5), 1997, pp. 380-386
The aim of this article is to review current issues concerning the sta
tistical determination of a withdrawal time for a veterinary drug, Spe
cial attention has been paid to the Food and Drug Administration (FDA)
approach which consists of using a regression method to estimate a 99
th percentile of the population with a 95% confidence level, The diffe
rent assumptions of the simple regression techniques are reviewed. It
is shown, both on theoretical grounds and using Monte Carlo simulation
s, that the main assumptions for the correct use of linear regression
do not hold when a tissue depletion curve is under investigation, Fina
lly, it is suggested that methods other than the regression technique
must be evaluated, especially a revised version of the so-called simpl
er approach, which consists of using a non-parametric strategy to esti
mate a withdrawal time.