The case study is based on project documentation, analyses of product and assembly concept, lab tests as well as dialogue with the manufacturer and the product designer.
In Europe, fewer than 30%% of marketed drugs include results from paediatric clinical trials and other information on paediatric use in their documentation (Summary of Product Characteristics, SPC or Product Leaflet, equivalent to US label) [ 3].
If an adverse event occurs after a switch from one biologic to another without documentation of the product change, the event would not be able to be linked to a specific product during pharmacovigilance assessment, or it could be ascribed to the wrong product.
The quality and safety have to be addressed in the application documentation of the drug product.
Accordingly, we have attempted to allow experimental methods and results to be described in significant detail, but without including parameters and properties that are likely to be superseded rapidly when new models of equipment are introduced, and without including parameters that can only be understood with reference to the documentation of a particular product.
A survey of product documentation acquired from Open Source Intelligence (OSINT) sources reveals patterns in the processes used to print objects with consumer 3D printer models used by 3D object printing services.
Finally, we recommend general adjustment of product documentation.
The study protocol, including informed consent documentation, insurance, and Summary of Product Characteristics, was approved by the hospital ethics committee and the study followed the guidelines of the Declaration of Helsinki.
Ideally, the original datasets are archived and published in a formal repository and the citation is used in the provenance documentation of the integrated data product.
