Article Dans Une Revue Journal of Veterinary Pharmacology and Therapeutics Année : 2012

Should licking behavior be considered in the bioavailability evaluation of transdermal products?

Résumé

Antiparasitic drugs, and especially macrocyclic lactones (MLs), are often formulated as pour-on products because of their ease of administration, convenience, and reduction of stress in treated animals. However, because of self- and allo-grooming, much of a drug administered transdermally may be systemically absorbed via the oral route, creating highly variable pharmacokinetic and pharmacodynamic response in treated (and untreated) animals. Testing bioequivalence (BE) of pour-on drugs in cattle under laboratory conditions (with restricted licking) ignores a major factor of drug disposition of these drugs and thus fails to predict therapeutic equivalence in the target population under clinical conditions of use. Therefore, the interanimal and intra-animal variability associated with licking behavior should be considered as a biological fact, rather than a noise that needs to be reduced or eliminated. As a result, it is recommended that the BE testing for pour-on products in cattle be conducted by evaluating both the mean and distribution of bioavailability parameters between the reference and test products when animals are not prevented from allo- and self-licking.

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hal-01136992 , version 1 (14-11-2015)

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Pierre-Louis Toutain, Sanja Modric, Alain Bousquet‐mélou, Juan M Sallovitz, Carlos Lanusse. Should licking behavior be considered in the bioavailability evaluation of transdermal products?. Journal of Veterinary Pharmacology and Therapeutics, 2012, 35, pp.39-43. ⟨10.1111/j.1365-2885.2012.01380.x⟩. ⟨hal-01136992⟩
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