Data sharing
Precompetitive data sharing initiatives that support risk assessments by providing fast access to high-quality data
We work collaboratively with industry members to develop data sharing initiatives that support precompetitive data sharing and industry progression
Sharing Ames mutagenicity results
Aromatic Amines
Advancing the understanding of Ames mutagenicity assays for primary aromatic amines.
Intermediates
Sharing Ames mutagenicity results for common intermediates and in vitro mammalian cell assays.
Complex Nitrosamines
Anonymously sharing Ames data on structurally complex nitrosamines.
Sharing excipient and vehicle toxicity data
Nitrites
Assessing the levels of nitrites in pharmaceutical excipients, solvents and reagents.
Elemental Impurities
Supporting more scientifically driven risk assessments under ICH Q3D.
Excipients
Facilitating data sharing on the tolerability of pharmaceutical excipient formulations.
Sharing Acceptable Intake (AI) and Permitted Daily Exposure (PDE) data
Sharing analytical and Ames data on nitrosamines
Nitrosamines
Sharing analytical data on the levels of nitrites in common excipients, reagents and solvents, and mutagenicity data on structurally-complex nitrosamines.
Additional data sharing collaborations
FDA Research Collaboration Agreement
Making use of publicly releasable FDA data to make improvements to our software.