title: GLP principles and their role in supporting pharmacokinetic and residue depletion studies for drug registration and licensing.
abstract: Good Laboratory Practice (GLP) is a quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived, and reported. This paper focuses on the GLP principles applicable for veterinary drug registration and licensing purposes. First, a general overview of the GLP requirements is given, followed by a more specific comparison and discussion of the analytical method validation parameters and acceptance criteria of different international guidelines applied in the context of veterinary drug pharmacokinetic and residue depletion studies. Finally, some needs with respect to method validation and new developments in pharmacokinetic and residue depletion studies are highlighted. Copyright © 2016 John Wiley & Sons, Ltd.
authors.affiliation: Laboratory of Pharmacology and Toxicology, Department of Pharmacology, Toxicology and Biochemistry, Faculty of Veterinary Medicine, Ghent University, Merelbeke, Belgium.
authors.forename: Siska
authors.initials: S
authors.lastname: Croubels
authors.affiliation: Laboratory of Pharmacology and Toxicology, Department of Pharmacology, Toxicology and Biochemistry, Faculty of Veterinary Medicine, Ghent University, Merelbeke, Belgium.
authors.forename: Patrick
authors.initials: P
authors.lastname: De Backer
authors.affiliation: Laboratory of Pharmacology and Toxicology, Department of Pharmacology, Toxicology and Biochemistry, Faculty of Veterinary Medicine, Ghent University, Merelbeke, Belgium.
authors.forename: Mathias
authors.initials: M
authors.lastname: Devreese
mesh_terms: D000818:Animals; D002623:Chemistry Techniques, Analytical / Q000379:methods*; D004350:Drug Residues / Q000032:analysis* / Q000493:pharmacokinetics*; D059022:Food Safety; D006801:Humans; D007753:Laboratories; D007880:Legislation, Drug; D054928:Validation Studies as Topic; D019155:Veterinary Drugs / Q000032:analysis* / Q000493:pharmacokinetics*
chemical_list: D019155:Veterinary Drugs
keywords: Good Laboratory Practice; pharmacokinetics; registration; residues; veterinary drug