Characterizing "Adversity" of Pathology Findings in Nonclinical Toxicity Studies: Results from the 4th ESTP International Expert Workshop.
The identification of adverse health effects has a central role in the development and risk/safety assessment of chemical entities and pharmaceuticals. There is currently a need for better alignment regarding how nonclinical adversity is determined and characterized. The European Society of Toxicologic Pathology (ESTP) therefore coordinated a workshop to review available definitions of adversity, weigh determining and qualifying factors of adversity based on case examples, and recommend a practical approach to define and characterize adversity in toxicology reports, to serve as a valuable prerequisite for future organ- or lesion-specific workshops planned by the ESTP.
Sanofi, Vitry-sur-Seine, France xavier.palazzi@sanofi.com.
Xavier
X
Palazzi
Pfizer Inc., Groton, CT, USA.
John E
JE
Burkhardt
Sanofi, Vitry-sur-Seine, France.
Henri
H
Caplain
Independent Consultant, Silver Spring, Maryland, USA.
Vicki
V
Dellarco
WIL Research, a Charles River Company, Lyon, France.
Pierluigi
P
Fant
Tox Path Science, Congleton, Cheshire, UK.
John R
JR
Foster
U.S. FDA, College Park, Maryland, USA.
Sabine
S
Francke
AbbVie, Ludwigshafen, Germany.
Paul
P
Germann
BASF, Ludwigshafen, Germany.
Sibylle
S
Gröters
Institute of Environmental Toxicology, Ibaraki, Japan.
Takanori
T
Harada
Fresenius Kabi, Bad Homburg, Germany.
Johannes
J
Harleman
Ishihara Sangyo Kaisha, Ltd., Osaka, Japan.
Kosei
K
Inui
Merck, Darmstadt, Germany.
Wolfgang
W
Kaufmann
Roche Pharmaceutical Research and Early Development, Basel, Switzerland.
Barbara
B
Lenz
Takeda Pharmaceutical Company Limited, Fujisawa, Kanagawa, Japan.
Hirofumi
H
Nagai
Kaleidis Consultancy, Saint-Louis, France.
Gabriele
G
Pohlmeyer-Esch
Federal Institute for Risk Assessment, Berlin, Germany.
Agnes
A
Schulte
Novo Nordisk A/S, Måløv, Denmark.
Mikala
M
Skydsgaard
Pfizer Inc., Groton, CT, USA.
Lindsay
L
Tomlinson
Office of Research and Development, U.S. EPA, Research Triangle Park, North Carolina, USA.
Charles E
CE
Wood
Food Safety Commission, Cabinet Office, Tokyo, Japan.
Midori
M
Yoshida
D000818:Animals; D064420:Drug-Related Side Effects and Adverse Reactions / Q000145:classification*; D017408:Guidelines as Topic; D006801:Humans; D018570:Risk Assessment; D000069436:Toxicological Phenomena; D014116:Toxicology / Q000592:standards*
LOAEL; NOAEL; adverse effect; adversity; hazard identification; toxicologic pathology