Suchergebnisse

Bovine hypodermosis (warble fly infestation) is a disease of cattle caused by flies whose larvae specifically parasitize cattle. This disease limits growth and milk production and seriously affects animal health. The results of studies conducted by INRAE and its partners have greatly contributed to the implementation of a program to eradicate hypodermosis in France. The disease has been totally under control since 2000.Bovine hypodermosis is caused by Hypoderma bovis and Hypoderma lineatum, non-biting flies, whose larvae specifically parasitize cattle. They cross the skin, migrate into deep tissues over several months, reach the dorsal subcutaneous tissue, where they cause abscesses, and finally pierce the skin of the animal migrating into the external environment.These parasites cause general immunosuppression, limiting the growth of young cattle and reducing milk production in cows. Further, they cause carcasses to be peeled at slaughter, produce serious damage to hides, and adversely affect animal welfare.In the 1980s, INRAE, together with Ecole Nationale Vétérinaire de Toulouse and other partners, conducted an ambitious research program, which sought to establish the epidemiology of Hypoderma species and identify a systematic treatment of animals without endangering consumers, breeders and animals. These essential conditions for implementing an effective strategy for controlling hypodermosis were achieved by administering a microdose of ivermectin and developing an immunodiagnosis that can be used on a very large scale with hypodermine C.Following proof of concept, achieved through the deployment of a bovine hypodermosis control plan in Brittany and then in Burgundy, the national control plan was gradually implemented throughout France by the Ministry of Agriculture and stakeholders. Within three years of implementation, the plan has led to control of this parasitic disease, and indeed to the disappearance of clinical cases of warble fly infestation. Thus, the outcome of studies conducted by INRAE and its ...

Bovine hypodermosis (warble fly infestation) is a disease of cattle caused by flies whose larvae specifically parasitize cattle. This disease limits growth and milk production and seriously affects animal health. The results of studies conducted by INRAE and its partners have greatly contributed to the implementation of a program to eradicate hypodermosis in France. The disease has been totally under control since 2000.Bovine hypodermosis is caused by Hypoderma bovis and Hypoderma lineatum, non-biting flies, whose larvae specifically parasitize cattle. They cross the skin, migrate into deep tissues over several months, reach the dorsal subcutaneous tissue, where they cause abscesses, and finally pierce the skin of the animal migrating into the external environment.These parasites cause general immunosuppression, limiting the growth of young cattle and reducing milk production in cows. Further, they cause carcasses to be peeled at slaughter, produce serious damage to hides, and adversely affect animal welfare.In the 1980s, INRAE, together with Ecole Nationale Vétérinaire de Toulouse and other partners, conducted an ambitious research program, which sought to establish the epidemiology of Hypoderma species and identify a systematic treatment of animals without endangering consumers, breeders and animals. These essential conditions for implementing an effective strategy for controlling hypodermosis were achieved by administering a microdose of ivermectin and developing an immunodiagnosis that can be used on a very large scale with hypodermine C.Following proof of concept, achieved through the deployment of a bovine hypodermosis control plan in Brittany and then in Burgundy, the national control plan was gradually implemented throughout France by the Ministry of Agriculture and stakeholders. Within three years of implementation, the plan has led to control of this parasitic disease, and indeed to the disappearance of clinical cases of warble fly infestation. Thus, the outcome of studies conducted by INRAE and its ...

Bovine hypodermosis (warble fly infestation) is a disease of cattle caused by flies whose larvae specifically parasitize cattle. This disease limits growth and milk production and seriously affects animal health. The results of studies conducted by INRAE and its partners have greatly contributed to the implementation of a program to eradicate hypodermosis in France. The disease has been totally under control since 2000.Bovine hypodermosis is caused by Hypoderma bovis and Hypoderma lineatum, non-biting flies, whose larvae specifically parasitize cattle. They cross the skin, migrate into deep tissues over several months, reach the dorsal subcutaneous tissue, where they cause abscesses, and finally pierce the skin of the animal migrating into the external environment.These parasites cause general immunosuppression, limiting the growth of young cattle and reducing milk production in cows. Further, they cause carcasses to be peeled at slaughter, produce serious damage to hides, and adversely affect animal welfare.In the 1980s, INRAE, together with Ecole Nationale Vétérinaire de Toulouse and other partners, conducted an ambitious research program, which sought to establish the epidemiology of Hypoderma species and identify a systematic treatment of animals without endangering consumers, breeders and animals. These essential conditions for implementing an effective strategy for controlling hypodermosis were achieved by administering a microdose of ivermectin and developing an immunodiagnosis that can be used on a very large scale with hypodermine C.Following proof of concept, achieved through the deployment of a bovine hypodermosis control plan in Brittany and then in Burgundy, the national control plan was gradually implemented throughout France by the Ministry of Agriculture and stakeholders. Within three years of implementation, the plan has led to control of this parasitic disease, and indeed to the disappearance of clinical cases of warble fly infestation. Thus, the outcome of studies conducted by INRAE and its ...

Les nématodes sont des vers appelés aussi helminthes, et les antiparasitaires vermifuges sont des anthelminthiques. L'ivermectine (IVM) est avec ses analogues actuellement le médicament le plus utilisé au monde pour traiter les nématodes gastro-intestinaux chez les animaux d'élevage. Elle est aussi largement utilisée en médecine humaine. Son efficacité à très faible dose, sa rémanence (durée d'action), son spectre d'action élargi (également acaricide et insecticide), et sa faible toxicité chez l'hôte (mammifère), font de l'IVM un antiparasitaire révolutionnaire au moment de son lancement sur le marché des médicaments vétérinaires dans les années 80. Pour mettre en œuvre les traitements anthelminthiques avec l'IVM, on peut recourir à trois formes galéniques (présentations) différentes : la solution injectable par voie sous-cutanée (SC) ; le « Pour-On » (PO), liquide destiné à être appliqué (versé) sur toute la longueur du dos de l'animal, et passant théoriquement dans l'organisme par voie transcutanée ; et le bolus, sorte de gros comprimé conçu pour diffuser de façon prolongée dans l'estomac des ruminants (rumen). L'INRA et l'ENVT ont étudié et documenté les expositions internes et les éliminations fécales en IVM associées à ces formes galéniques, car ces connaissances sont indispensables pour répondre à des enjeux de santé publique en anticipant d'éventuels problèmes de sûreté (hygiène) alimentaire pour le consommateur, de toxicité pour l'animal et pour l'environnement, et d'efficacité (résistance des parasites). Ce programme a été réalisé en collaboration avec l'Université Paul Valéry de Montpellier, l'Université de Melbourne (Australie) et, pour les recommandations d'évolution réglementaire (AMM), la FDA (USA). En termes d'impact politique, les travaux de l'INRA sur l'IVM et les publications internationales ont été déclencheurs pour prendre en compte l'écotoxicologie et le comportement social des animaux (le PO devient une quasi voie orale par effet léchage) pour l'évaluation réglementaire des médicaments. ...

Les nématodes sont des vers appelés aussi helminthes, et les antiparasitaires vermifuges sont des anthelminthiques. L'ivermectine (IVM) est avec ses analogues actuellement le médicament le plus utilisé au monde pour traiter les nématodes gastro-intestinaux chez les animaux d'élevage. Elle est aussi largement utilisée en médecine humaine. Son efficacité à très faible dose, sa rémanence (durée d'action), son spectre d'action élargi (également acaricide et insecticide), et sa faible toxicité chez l'hôte (mammifère), font de l'IVM un antiparasitaire révolutionnaire au moment de son lancement sur le marché des médicaments vétérinaires dans les années 80. Pour mettre en œuvre les traitements anthelminthiques avec l'IVM, on peut recourir à trois formes galéniques (présentations) différentes : la solution injectable par voie sous-cutanée (SC) ; le « Pour-On » (PO), liquide destiné à être appliqué (versé) sur toute la longueur du dos de l'animal, et passant théoriquement dans l'organisme par voie transcutanée ; et le bolus, sorte de gros comprimé conçu pour diffuser de façon prolongée dans l'estomac des ruminants (rumen). L'INRA et l'ENVT ont étudié et documenté les expositions internes et les éliminations fécales en IVM associées à ces formes galéniques, car ces connaissances sont indispensables pour répondre à des enjeux de santé publique en anticipant d'éventuels problèmes de sûreté (hygiène) alimentaire pour le consommateur, de toxicité pour l'animal et pour l'environnement, et d'efficacité (résistance des parasites). Ce programme a été réalisé en collaboration avec l'Université Paul Valéry de Montpellier, l'Université de Melbourne (Australie) et, pour les recommandations d'évolution réglementaire (AMM), la FDA (USA). En termes d'impact politique, les travaux de l'INRA sur l'IVM et les publications internationales ont été déclencheurs pour prendre en compte l'écotoxicologie et le comportement social des animaux (le PO devient une quasi voie orale par effet léchage) pour l'évaluation réglementaire des médicaments. ...

International audience ; In France, more than 2.5 million patients are currently treated with levothyroxine, mainly as the marketed product Levothyrox ®. In March 2017, at the request of French authorities, a new formulation of Levothyrox ® was licensed, with the objective of avoiding stability deficiencies of the old formulation. Before launching this new formulation, an average bioequivalence trial, based on European Union recommended guidelines, was performed. The implicit rationale was the assumption that the two products, being bioequivalent, would also be switchable, allowing substitution of the new for the old formulation, thus avoiding the need for individual calibration of the dosage regimen of thyroxine, using the thyroid-stimulating hormone level as the endpoint, as required for a new patient on initiating treatment. Despite the fact that both formulations were shown to be bioequivalent, adverse drug reactions were reported in several thousands of patients after taking the new formulation. In this opinion paper, we report that more than 50% of healthy volunteers enrolled in a successful regulatory average bioequivalence trial were actually outside the a priori bioequivalence range. Therefore, we question the ability of an average bioequivalence trial to guarantee the switchability within patients of the new and old levothyroxine formulations. We further propose an analysis of this problem using the conceptual framework of individual bioequivalence. This involves investigating the bioavailability of the two formulations within a subject, by comparing not only the population means (as established by average bioequivalence) but also by assessing two variance terms, namely the within-subject variance and the variance estimating subject-by-formulation interaction. A higher within individual variability for the new formulation would lead to reconsideration of the appropriateness of the new formulation. Alternatively, a possible subject-by-formulation interaction would allow a judgement on the ability, or ...

was licensed, with the objective of avoiding stability deficiencies of the old formulation. Before launching this new formulation, an average bioequivalence trial, based on European Union recommended guidelines, was performed. The implicit rationale was the assumption that the two products, being bioequivalent, would also be switchable, allowing substitution of the new for the old formulation, thus avoiding the need for individual calibration of the dosage regimen of thyroxine, using the thyroid-stimulating hormone level as the endpoint, as required for a new patient on initiating treatment. Despite the fact that both formulations were shown to be bioequivalent, adverse drug reactions were reported in several thousands of patients after taking the new formulation. In this opinion paper, we report that more than 50% of healthy volunteers enrolled in a successful regulatory average bioequivalence trial were actually outside the a priori bioequivalence range. Therefore, we question the ability of an average bioequivalence trial to guarantee the switchability within patients of the new and old levothyroxine formulations. We further propose an analysis of this problem using the conceptual framework of individual bioequivalence. This involves investigating the bioavailability of the two formulations within a subject, by comparing not only the population means (as established by average bioequivalence) but also by assessing two variance terms, namely the within-subject variance and the variance estimating subject-by-formulation interaction. A higher within individual variability for the new formulation would lead to reconsideration of the appropriateness of the new formulation. Alternatively, a possible subject-by-formulation interaction would allow a judgement on the ability, or not, of doctors to manage patients effectively during transition from the old to the new formulation.