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. 2026 Jan 20;14(1):92. doi: 10.3390/toxics14010092
3R Replacement, Reduction, Refinement
AE Acceptable exposure
AET Analytical Evaluation Threshold
AI Acceptable intake
bDtBPP bis(2,4-di-tert-butylphenyl)phosphate
BHT Butylated hydroxytoluene
BPA Bisphenol A
CHO Chinese Hamster Ovary
DEHP Di(2-ethylhexyl) phthalate
DNA deoxyribonucleic acid
DP Drug product
DS Drug substance
EC3 Estimated concentration 3
ECHA European Chemicals Agency
EDE Estimated daily exposure
ELSIE Extractables and Leachables Safety Information Exchange
EMA European Medicines Agency
EPO Erythropoietin
EU European Union
E&L Extractables and leachables
FDA Food and Drug Administration
GLP Good laboratory practice
IgG Immunoglobulin G
IUPAC International union of pure and applied chemistry
LOD Limit of Detection
LOEL Lowest observed effect level
LOQ Limit of Quantitation
LTL Less-than-lifetime
LVP Large-volume parenterals
MBT 2-Mercapto-benzothiazole
MoS Margin of safety
NAMs New Approach Methodologies
NDBA N-Nitrosodibutylamine
NDMA N-Nitrosodimethylamine
NOAEL No observed adverse effect level
NOEL No observed effect level
OECD Organization for Economic Co-operation and Development
OINDP Orally inhaled and nasal drug products
PAHs Polycyclic aromatic hydrocarbons
PDE Permitted daily exposure
PDP Parenteral drug products
PFAS Per- and polyfluoroalkyl substances
PNAs Polynuclear aromatic hydrocarbons
POD Point of departure
PODP Parenteral and Ophthalmic Drug Product
ppm Parts per million
PPWR Packaging and Packaging Waste Regulation
PQRI Product Quality Research Institute
PRCA Pure red cell aplasia
PTFE Polytetrafluoroethylene
PVC Polyvinyl chloride
REACH Registration, Evaluation, Authorisation and Restriction of Chemicals
QSAR Quantitative structure-activity relationship
QT Qualification threshold
RSD Relative standard deviation
SAR Structure–activity relationship
SCT Safety concern threshold
TD50 Tumorigenic dose 50
TSCA Toxic Substances Control Act
TTC Threshold of toxicological concern
UN United Nations
USP United States Pharmacopeia
UV Ultraviolet
V(MDD) Volume of maximum daily dose