Title
Food allergy population thresholds: An evaluation of the number of oral food challenges and dosing schemes on the accuracy of threshold dose distribution modeling
Author
Klein Entink, R.H.
Remington, B.C.
Blom, W.M.
Rubingh, C.M.
Kruizinga, A.G.
Baumert, J.L.
Taylor, S.L.
Houben, G.F.
Publication year
2014
Abstract
For most allergenic foods, limited availability of threshold dose information within the population restricts the advice on action levels of unintended allergenic foods which should trigger advisory labeling on packaged foods.The objective of this paper is to provide guidance for selecting an optimal sample size for threshold dosing studies for major allergenic foods and to identify factors influencing the accuracy of estimation. A simulation study was performed to evaluate the effects of sample size and dosing schemes on the accuracy of the threshold distribution curve. The relationships between sample size, dosing scheme and the employed statistical distribution on the one hand and accuracy of estimation on the other hand were obtained. It showed that the largest relative gains in accuracy are obtained when sample size increases from N= 20 to N= 60. Moreover, it showed that the EuroPrevall dosing scheme is a useful start, but that it may need revision for a specific allergen as more data become available, because a proper allocation of the dosing steps is important.The results may guide risk assessors in minimum sample sizes for new studies and in the allocation of proper dosing schemes for allergens in provocation studies. © 2014 Elsevier Ltd.
Subject
Life
RAPID - Risk Assessment Products in Development
ELSS - Earth, Life and Social Sciences
Food and Nutrition
Nutrition
Healthy Living
Allergenic foods
Simulation study
Threshold dose distribution
food allergen
accuracy
food allergy
nutritional parameters
provocation test
sample size
statistical distribution
statistical model
threshold dose distribution
To reference this document use:
http://resolver.tudelft.nl/uuid:fd657ed8-91f5-48e5-9e1b-f3f8c599e60b
DOI
https://doi.org/10.1016/j.fct.2014.05.001
TNO identifier
507113
Publisher
Elsevier Ltd
ISSN
1873-6351
Source
Food and Chemical Toxicology, 70, 134-143
Document type
article