Interspecies considerations in the evaluation of human food safety for veterinary drugs

Abstract

Residues are composed of the parent drug and metabolites, and therefore interspecies comparisons must involve a consideration of comparative xenobiotic metabolism. The focus of this article will be the residue studies that are required to establish human food safety, and the interspecies pharmacokinetic differences and similarities that impact drug residues in animal-derived foods. To illustrate the factors that can complicate and assist these comparisons, 2 drugs will be examined in detail: ivermectin and fenbendazole. In addition, the activities of 2 US programs, the Food Animal Residue Avoidance Databank (FARAD) and the NRSP-7 (National Research Support Project Number 7) Minor Use Animal Drug Program will be presented, along with strategies that may be employed in the study of species differences.

Interspecies allometric scaling: prediction of clearance in large animal species: Part II: mathematical considerations

“…In this regard, among its uses, it is especially important for estimating an appropriate dose in large animal species for which there does not exist pharmacokinetic or clinical information to support dose estimation (Hunter & Isaza, 2002; Isaza & Hunter, 2004). It is also used to predict a terminal elimination half‐life value, which may be applied by extension services such as the FARAD (http://www.farad.org) for estimating withdrawal times when drugs are administered to food‐producing animals in an extralabel manner (Craigmill & Cortright, 2002).…”

“…It is also used to predict a terminal elimination half-life value, which may be applied by extension services such as the FARAD (http://www. farad.org) for estimating withdrawal times when drugs are administered to food-producing animals in an extralabel manner (Craigmill & Cortright, 2002).…”

Fish drug analysis—Phish-pharm: A searchable database of pharmacokinetics data in fish

“…9 One strategy being explored for aquaculture drug products is to group species according to those species of fish likely to present with similar safety profiles, effectiveness characteristics, or withdrawal times. [10][11][12][13][14][15][16] Several approaches have been suggested for this "crop grouping," and the proposed basis for grouping species has included taxonomic class, salinity tolerance, or water temperature.…”

“…9 One strategy being explored for aquaculture drug products is to group species according to those species of fish likely to present with similar safety profiles, effectiveness characteristics, or withdrawal times. [10][11][12][13][14][15][16] Several approaches have been suggested for this "crop grouping," and the proposed basis for grouping species has included taxonomic class, salinity tolerance, or water temperature.The underlying theory for a taxonomic grouping is that organisms closely related phylogenetically might be expected to have similar drug metabolism and elimination. This is definitely the case in fish lacking certain renal elements such as glomeruli and distal tubules.…”

Challenges and issues in veterinary pharmacology and animal health 2004—Preface

“…Arthur L. Craigmill and Kristy A. Cortright wrote an article on the Evaluation of Human Food Safety for Veterinary Drugs. 12 In that article, they described the assumptions and algorithms associated with the establishment of a withdrawal time (time between the last drug administration and the slaughter of the animal for human consumption), the latter being based upon some maximum allowable daily intake (MRL) of drug residues in food.…”