English: 7.1.3 Curriculum Vitae of Investigators -----------------------------------------------------------------------------------3 7.2 TARGET ANIMAL SAFETY STUDIES ----------------------------------------------------------------------------------------3 7.2.1 Comprehensive Summary ---------------------------------------------------------------------------------------------3 7.2.2 Sectional Reports-------------------------------------------------------------------------------------------------------3 7.2.2.1 7.2.2.2 7.2.2.3 7.2.2.4 7.2.2.5 7.2.2.6 7.2.2.7 7.2.2.8 7.2.2.9 Margin-of-Safety Studies ------------------------------------------------------------------------------------------------------- 3 Safety Under the Proposed Conditions of Use ------------------------------------------------------------------------------- 3 Topical Drug Studies ------------------------------------------------------------------------------------------------------------ 3 Inhalant Drug Studies ----------------------------------------------------------------------------------------------------------- 3 Tissue Irritation Studies --------------------------------------------------------------------------------------------------------- 3 Udder Irritation Studies --------------------------------------------------------------------------------------------------------- 3 Reproductive Function Studies------------------------------------------------------------------------------------------------- 3 Clinical Safety Studies ---------------------------------------------------------------------------------------------------------- 3 Pharmacovigilance Data -------------------------------------------------------------------------------------------------------- 3
French: 7.1.3 Curriculum vitæ des chercheurs ----------------------------------------------------------------------------------- 84 7.2 ÉTUDES D’INNOCUITÉ POUR LES ANIMAUX CIBLÉS --------------------------------------------------------------------- 84 7.2.1 Sommaire détaillé ---------------------------------------------------------------------------------------------------- 84 7.2.2 Rapports de section -------------------------------------------------------------------------------------------------- 85 7.2.2.1 7.2.2.2 7.2.2.3 7.2.2.4 7.2.2.5 7.2.2.6 7.2.2.7 7.2.2.8 7.2.2.9 Études de détermination de la marge d’innocuité ------------------------------------------------------------------------- 85 Innocuité dans les conditions d’utilisation proposées --------------------------------------------------------------------- 86 Études de drogue topique ----------------------------------------------------------------------------------------------------- 86 Études de médicaments administrés par inhalation------------------------------------------------------------------------ 87 Études d’irritation des tissus-------------------------------------------------------------------------------------------------- 87 Études d’irritation du pis ------------------------------------------------------------------------------------------------------ 87 Étude des fonctions de reproduction ---------------------------------------------------------------------------------------- 88 Études d’innocuité clinique--------------------------------------------------------------------------------------------------- 88 Données de pharmacovigilance ---------------------------------------------------------------------------------------------- 88