Selection and interpretation of clinical pathology indicators of hepatic injury in preclinical studies.
This position paper delineates the expert recommendations of the Regulatory Affairs Committee of the American Society for Veterinary Clinical Pathology for the use of preclinical, clinical pathology endpoints in assessment of the potential for drug-induced hepatic injury in animals and humans. Development of these guidelines has been based on current recommendations in the relevant preclinical and human clinical trial literature; they are intended to provide a method for consistent and rigorous interpretation of liver-specific data for the identification of hepatic injury in preclinical studies and potential liability for hepatic injury in human patients.
Boone
L
L
Regulatory Affairs Committee of the American Society for Veterinary Clinical Pathology, USA. boone_laura_I@lilly.com
Meyer
D
D
Cusick
P
P
Ennulat
D
D
Bolliger
A Provencher
AP
Everds
N
N
Meador
V
V
Elliott
G
G
Honor
D
D
Bounous
D
D
Jordan
H
H
D000818:Animals; D004195:Disease Models, Animal; D008099:Liver / Q000293:injuries* / Q000473:pathology*; D008111:Liver Function Tests; D010336:Pathology / Q000193:education*; D012449:Safety; D014730:Veterinary Medicine / Q000639:trends*