Abstract: . . .  Double blind challenge, 7 active doses, 7 placebo Randomly interspersed, 15 30 min interval 85% defatted roasted peanut flour in mashed potatoes 26/26 had symptoms, 5/26 objective Symptoms: OAS (26), lipswelling (3), nausea (2), vomiting (2) Clinical score: mild, moderate, severe      Age (mean)     ED obj (g)      ED obj (cum) (g)    25           10 - 30             14.43 44   Wensing  et al. JACI 2002;110:915-20.   Food Allergy Research and Resource Program 2005     Food Allergy Research and Resource Program 2005     Uncertainties Regarding Establishment of Threshold Doses   LOAELs vs. NOAELs Uncertainty in using LOAEL to establish threshold dose Patient selection and exclusion of severely affected patients Variability in individual threshold doses  . . .
. . .    2 nd Threshold Conference   Results : Taylor et al. 2004. A consensus protocol for the determination of the threshold doses for allergenic foods:  how much is too much? Clin. Exp. Allergy 34: 689-695.   3 rd FARRP Threshold Conference   October 4-5, 2004 Camp De Mar, Mallorca, Spain   Food Allergy Research and Resource Program 2005     Why model dose-response?   It may not be feasible to design studies with sufficient power to give the desired degree of safety assurance (e.g., 268 patients and no reactions are required to say with 95% confidence that the reaction rate is less than 1%). A conventional approach, applying a safety factor to a no effect level cannot easily be applied: many challenge studies do not yield a no-effect level some challenge studies exclude individuals who have suffered a severe response, (are severe reactors the most sensitive?) No agreement yet on uncertainty factors Modelling is an accepted way of defining the probability of rare events with potentially severe consequences     Figure 4: Diagram showing one possible definition for a allergen threshold using a log-linear model.   Food Allergy Research and Resource Program 2005     Classical Risk Assessment   Typical Uncertainty Factors:      . . .
--3000,2,750,2746,15999