A description of the procedures, including materiel and equipment, needed to prepare samples for analysis in the five demonstration project studies in WP4 of IMI2 JU ConcePTION.
4.3 has developed information and consent procedures for recruitment of potential participants in collection of breast milk samples for storage in a European Biobank and subsequently being used for pharmacokinetic analyses of if, and to what extent, medical drugs transfer from breast milk to the breast feeding child. In addition, procedures for collecting breast milk and blood have been developed to facilitate research collecting blood and breast milk. The procedures and templates are designed to fit five demonstration studies within the following therapeutic areas and for the following drugs:
- Diabetes – metformin
- Bacterial Infection – amoxicillin
- Allergy – cetirizine
- Depression – venlafaxine
- Rheumatologic and Inflammatory Bowel Diseases – infliximab.
This report provides a description of the procedures, including materiel and equipment needed to prepare samples for analysis. To reduce patient burden and to promote feasibility, we provide procedures for sampling at the clinical sites as well as for sampling at the participants’ homes. These procedures should be used to harmonise sample collection when it is performed at multiple sites. The procedures provide a general description of how to collect samples of blood and breast milk and require adaption to apply to the specific study, local conditions and national legislations and regulations. The procedures will be validated with regard to bioanalytic properties and conditions and changed accordingly if needed before inclusion in study protocols.
