Results

 

The latest key achievements of the consortium work:

- The Drug induced liver injury work package of Innovative Medicines Initiative SAFE-T Consortium and The Hepatotoxicity Working Group of Critical Path Institutes PSTC presents the "Summary Data Package Novel clinical biomarkers of Drug-Induced Liver Injury" to share these with the scientific community. (published the 05 oct 2016)

    The SAFE-T consortium presents here their current versions of the SOPs for the validation of the SAFE-T biomarker candidate assays to share these with the scientific community. These documents are showing work in progress and may be exchanged by updated versions:

- Quality control of biomarker enzymatic activity and immunoassay testing (version 3.5  ;  date: 14 April 2015)
- Standard validation procedure for biomarker immunoassays (version 4.1  ; 14 April 2015)
- Immuno-Assay Validation Report template (version 2.0   January 2015)

 

-Generic Clinical Qualification Process for Translational Safety Biomarkers

-DIKI BM qualification strategy: A consortium for the regulatory qualification of human kidney biomarkers to monitor drug-induced kidney injury -SAFE-T_ERAEDTA_FINAL.pdf

-DILI BM qualification strategy: DILI article in Regulatory Toxicology and Pharmacology -DILI.pdf ;

-DILI conference March 24 2011QUALIFICATION_OF_NEW_TRANSLATIONAL_SAFETY_BIOMARKERS.pdf

-DIVI BM qualification strategy: -DIVI_BM_qualification_strategy.pdf  -DIVI_update_for_IMI.pdf

-The SAFE-T Consortium: A Collaborative Approach for the Qualification of Novel Kidney Biomarkers with the Regulatory Authorities Collaborative_approach_for_the_qualification_of_novel_kidney_biomarkers_with_regulatory_authorities.pdf Development of

-Biomarkers and Translation Strategy for Drug-Induced Vascular Injury  BMs_and_translation_strategy_for_DIVI.pdf

-Immunoassays in Multiplex for Personalized Medicine Immunoassays_in_multiplex_for_personalized_medicine.pdf

-Clinical biomarker qualification for drug-induced injury to kidney, liver and the vascular system within SAFE-T Clinical_qualification_for_DIKI_DILI_and_DIVI_within_SAFE_T.pdf

-Qualification of clinical biomarkers of DILI: Current gaps, research efforts, and future directions Qualification_of_clinical_BMs_of_DILI.pdf

-Safety Biomarkers: Opportunities and challenges in drug discovery and development Safety_Biomarkers.pdf

-IMI project - SAFE-T An European consortium approach to renal safety biomarkers An_European_Consortium_approach_to_renal_safety_biomarkers.pdf

 
Results