Abstract

The dataset contains data about amoxicillin quantification in milk and blood collected from lactating sows and in piglets’ blood, obtained in the framework of the Horizon 2020 IMI funded project ConcePTION. The main goal of ConcePTION is to establish a trusted ecosystem that can efficiently, systematically, and in an ethically responsible manner, generate and disseminate reliable evidence-based information regarding effects of medications used during pregnancy and breastfeeding to women and their healthcare providers. This will be achieved by generating, cataloguing, linking, collecting and analysing data from pharmacovigilance, modelling, routine healthcare, breastmilk samples through a large network. Within such framework, task 3.3 of WP3 aims at developing and characterising a relevant in vivo model for drug passage from maternal blood to human breast milk. Based on a preliminary scan of existing literature, the chosen species to perform such non-clinical trial was the porcine one due to high anatomical and physiological similarities. In the initial trial, amoxicillin was chosen as the first molecule for a variety of reasons including alignment with other Work Packages (WPs) performing studies on human breastmilk. Additionally, since amoxicillin is commonly used in pigs, the choice of the route of administration, the administration interval and the doses were supported by reliable background data.