Division 2.1 Pharmacokinetics (absorption, distribution, metabolism, excretion)F1
United Kingdom
A summary of the pharmacokinetic data shall be submitted with cross reference to the pharmacokinetic studies in target species submitted in Part 4. The full study report does not need to be submitted.
The purpose of pharmacokinetic studies with respect to residues of veterinary medicinal products is to evaluate the absorption, distribution, metabolism and excretion of the product in the target species.
The final product, or a formulation, which has comparable characteristics in terms of bioavailability as the final product, shall be administered to the target animal species at the maximum recommended dose.
Having regard to the method of administration, the extent of absorption of the veterinary medicinal product shall be fully described. If it is demonstrated that systemic absorption of products for topical application is negligible, further residue studies will not be required.
The distribution of the veterinary medicinal product in the target animal shall be described; the possibility of plasma protein binding or passage into milk or eggs and of the accumulation of lipophilic compounds shall be considered.
The pathways for the excretion of the product from the target animal shall be described. The major metabolites shall be identified and characterised.