In vivo data on lactation transfer in one or more animal species

Task 33 In vivo experiments in lactating nonclinical species likely Gttingen minipig andor pig farm breed M4M48 UNIBO Ellegaard Bionotus Covance Lilly NVS Teva The aim is to develop and characterise an improved in vivo model for drug passage from maternal blood to human breast milk The primary criterion when choosing a preclinical animal model must be its translational value which is dependent on its analogies with the human species The literature search performed in Task 31 will be used to inform andor confirm the selection of the appropriate species Currently the use of rodent species leads to the common view that animal data are generally not useful in predicting drug concentrations in human milk 14 However a porcine species may represent a more suitable model with better anatomical and physiological thus metabolic similarities15 These in vivo studies will use innovative designs considering the possibility for microdosing cassette dosing and blood sampling in offspring Such approaches are expected to maximise the amount of data generated in the animal model consistent with the 3R principle Compound selection will be based on the criteria described in task 31 and the compounds already selected in Task 32 Sensitive LCMSMS methods will be developed and validated according to EMAFDA guidelines and EBF recommendations Bioanalytical method details will be shared with WP4 for corresponding model drugs