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

Autores
Toutain, P. L.; Modric, S.; Bousquet Mélou, A.; Sallovitz, Juan Manuel; Lanusse, Carlos Edmundo
Año de publicación
2012
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
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.
Fil: Toutain, P. L.. Institut National de la Recherche Agronomique; Francia. Université de Toulouse; Francia
Fil: Modric, S.. Food and Drug Administration; Estados Unidos
Fil: Bousquet Mélou, A.. Institut National de la Recherche Agronomique; Francia. Université de Toulouse; Francia
Fil: Sallovitz, Juan Manuel. Universidad Nacional del Centro de la Provincia de Buenos Aires. Facultad de Ciencias Veterinarias. Departamento de Fisiopatologia; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: Lanusse, Carlos Edmundo. Universidad Nacional del Centro de la Provincia de Buenos Aires. Facultad de Ciencias Veterinarias. Departamento de Fisiopatologia; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Materia
Licking Behaviour
Moxidectin
Bovine
Percutaneous Absorption
Nivel de accesibilidad
acceso abierto
Condiciones de uso
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
Repositorio
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/70783
Acceder
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network_name_str CONICET Digital (CONICET)
spelling Should licking behavior be considered in the bioavailability evaluation of transdermal products?Toutain, P. L.Modric, S.Bousquet Mélou, A.Sallovitz, Juan ManuelLanusse, Carlos EdmundoLicking BehaviourMoxidectinBovinePercutaneous Absorptionhttps://purl.org/becyt/ford/4.3https://purl.org/becyt/ford/4Antiparasitic 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.Fil: Toutain, P. L.. Institut National de la Recherche Agronomique; Francia. Université de Toulouse; FranciaFil: Modric, S.. Food and Drug Administration; Estados UnidosFil: Bousquet Mélou, A.. Institut National de la Recherche Agronomique; Francia. Université de Toulouse; FranciaFil: Sallovitz, Juan Manuel. Universidad Nacional del Centro de la Provincia de Buenos Aires. Facultad de Ciencias Veterinarias. Departamento de Fisiopatologia; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Lanusse, Carlos Edmundo. Universidad Nacional del Centro de la Provincia de Buenos Aires. Facultad de Ciencias Veterinarias. Departamento de Fisiopatologia; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaWiley Blackwell Publishing, Inc2012-04info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/70783Toutain, P. L.; Modric, S.; Bousquet Mélou, A.; Sallovitz, Juan Manuel; Lanusse, Carlos Edmundo; Should licking behavior be considered in the bioavailability evaluation of transdermal products?; Wiley Blackwell Publishing, Inc; Journal of Veterinary Pharmacology and Therapeutics; 35; SUPPL. 1; 4-2012; 39-430140-7783CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/doi/10.1111/j.1365-2885.2012.01380.xinfo:eu-repo/semantics/altIdentifier/url/https://onlinelibrary.wiley.com/doi/abs/10.1111/j.1365-2885.2012.01380.xinfo:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-10-22T11:13:59Zoai:ri.conicet.gov.ar:11336/70783instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982025-10-22 11:13:59.951CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Should licking behavior be considered in the bioavailability evaluation of transdermal products?
title Should licking behavior be considered in the bioavailability evaluation of transdermal products?
spellingShingle Should licking behavior be considered in the bioavailability evaluation of transdermal products?
Toutain, P. L.
Licking Behaviour
Moxidectin
Bovine
Percutaneous Absorption
title_short Should licking behavior be considered in the bioavailability evaluation of transdermal products?
title_full Should licking behavior be considered in the bioavailability evaluation of transdermal products?
title_fullStr Should licking behavior be considered in the bioavailability evaluation of transdermal products?
title_full_unstemmed Should licking behavior be considered in the bioavailability evaluation of transdermal products?
title_sort Should licking behavior be considered in the bioavailability evaluation of transdermal products?
dc.creator.none.fl_str_mv Toutain, P. L.
Modric, S.
Bousquet Mélou, A.
Sallovitz, Juan Manuel
Lanusse, Carlos Edmundo
author Toutain, P. L.
author_facet Toutain, P. L.
Modric, S.
Bousquet Mélou, A.
Sallovitz, Juan Manuel
Lanusse, Carlos Edmundo
author_role author
author2 Modric, S.
Bousquet Mélou, A.
Sallovitz, Juan Manuel
Lanusse, Carlos Edmundo
author2_role author
author
author
author
dc.subject.none.fl_str_mv Licking Behaviour
Moxidectin
Bovine
Percutaneous Absorption
topic Licking Behaviour
Moxidectin
Bovine
Percutaneous Absorption
purl_subject.fl_str_mv https://purl.org/becyt/ford/4.3
https://purl.org/becyt/ford/4
dc.description.none.fl_txt_mv 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.
Fil: Toutain, P. L.. Institut National de la Recherche Agronomique; Francia. Université de Toulouse; Francia
Fil: Modric, S.. Food and Drug Administration; Estados Unidos
Fil: Bousquet Mélou, A.. Institut National de la Recherche Agronomique; Francia. Université de Toulouse; Francia
Fil: Sallovitz, Juan Manuel. Universidad Nacional del Centro de la Provincia de Buenos Aires. Facultad de Ciencias Veterinarias. Departamento de Fisiopatologia; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: Lanusse, Carlos Edmundo. Universidad Nacional del Centro de la Provincia de Buenos Aires. Facultad de Ciencias Veterinarias. Departamento de Fisiopatologia; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
description 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.
publishDate 2012
dc.date.none.fl_str_mv 2012-04
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
http://purl.org/coar/resource_type/c_6501
info:ar-repo/semantics/articulo
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/11336/70783
Toutain, P. L.; Modric, S.; Bousquet Mélou, A.; Sallovitz, Juan Manuel; Lanusse, Carlos Edmundo; Should licking behavior be considered in the bioavailability evaluation of transdermal products?; Wiley Blackwell Publishing, Inc; Journal of Veterinary Pharmacology and Therapeutics; 35; SUPPL. 1; 4-2012; 39-43
0140-7783
CONICET Digital
CONICET
url http://hdl.handle.net/11336/70783
identifier_str_mv Toutain, P. L.; Modric, S.; Bousquet Mélou, A.; Sallovitz, Juan Manuel; Lanusse, Carlos Edmundo; Should licking behavior be considered in the bioavailability evaluation of transdermal products?; Wiley Blackwell Publishing, Inc; Journal of Veterinary Pharmacology and Therapeutics; 35; SUPPL. 1; 4-2012; 39-43
0140-7783
CONICET Digital
CONICET
dc.language.none.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/doi/10.1111/j.1365-2885.2012.01380.x
info:eu-repo/semantics/altIdentifier/url/https://onlinelibrary.wiley.com/doi/abs/10.1111/j.1365-2885.2012.01380.x
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
eu_rights_str_mv openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
dc.format.none.fl_str_mv application/pdf
application/pdf
application/pdf
dc.publisher.none.fl_str_mv Wiley Blackwell Publishing, Inc
publisher.none.fl_str_mv Wiley Blackwell Publishing, Inc
dc.source.none.fl_str_mv reponame:CONICET Digital (CONICET)
instname:Consejo Nacional de Investigaciones Científicas y Técnicas
reponame_str CONICET Digital (CONICET)
collection CONICET Digital (CONICET)
instname_str Consejo Nacional de Investigaciones Científicas y Técnicas
repository.name.fl_str_mv CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicas
repository.mail.fl_str_mv dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar
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score 12.982451

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