E N D
2. Drug Induced Liver Injury Network DILIN Cooperative Agreement
5. DILIN: Sphere of Influence
8. DILIN First Phase
working definitions for drug-induced liver toxicity,
diagnostic algorithms,
causality assessment protocol or instrument,
study design to identify cases,
manual of operations for clinical data & specimen collection, and patient consent form.
Second Phase
implement operating procedures,
enroll patients and control subjects,
capture data and samples (serum, tissue, DNA).
9.
10. Protocol #1: ILIAD specific aims
1. To establish and maintain a clinical database on patients who have suffered severe idiosyncratic DILI.
2. Establish a bank of biological specimens (serum, DNA, and immortalized lymphocytes) prepared from cases and suitable controls.
11. ILIAD specific aims, con’t 3). Maintain a registry, including yearly updated contact information of the subjects enrolled in the clinical database so that it is possible to recontact these individuals at a later date to offer participation in phenotype/genotype studies.
12. Considerations for target drugs for ILIAD
13. Drugs Targeted(target n= 50-100 / drug)
1). INH
2). valproate
3). phenytoin
4). amoxacillin/clavulanic acid
14.
15.
16.
17.
18.
19.