Pharmaceutical toxicology: Designing studies to reduce animal use, while maximizing human translation
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Abbreviations
3Rs
replacement, refinement and reduction of animals in research
ACSA
Agricultural Chemicals Safety Assessment
ADA
anti-drug antibody
CNS
central nervous system
DBS
dried blood spot
DART
developmental and reproductive toxicity
DRF
dose range finding
ECG
electrocardiograph
EFD
embryofetal development
EPA
environmental protection agency
ePPND
enhanced peri-postnatal toxicity study
GLP
Good Laboratory Practice
hERG
human Ether-a-Go-go Related Gene
ICATM
International Cooperation on Alternative Test Methods
ICH
International Conference for Harmonisation
ILSI-HESI
International Life Sciences Institute Health and Environmental Sciences Institute
IND
investigational new drug
JET
jacketed external telemetry
LLNA
Local Lymph Node Assay
mAb
monoclonal antibody
NHP
non-human primate
NRC
National Research Council
OECD
Organisation for Economic Co-operation and Development
PD
pharmacodynamic
PK
pharmacokinetic
PPND
peri-postnatal toxicity study
TK
toxicokinetic
Keywords
Safety
Toxicology
3Rs
In vitro methods
Safety pharmacology
Rodents
Biologicals
New chemical entities
Developmental
Reproductive
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