TY - ECHAP
KW - Endotoxin
KW - European pharmacopeia
KW - Monocyte activation test (MAT)
KW - Nonanimal replacement
KW - Pyrogenicity
KW - Rabbit pyrogen test (RPT)
KW - United States pharmacopeia
AU - Justine C. Watkins
AU - Thomas Hartung
AU - Ingrid Visseren-Hamakers
AU - Dilyana Filipova
AU - Howard White
AU - Luisa Ferreira Bastos
AU - Love Hansell
AU - Merel Ritskes-Hoitinga
AU - Catharine E. Krebs
AU - Gail A. Van Norman
AB - Efforts to replace animal testing with human-relevant methods have advanced. Pyrogenicity quality control testing illustrates the progress of this transition well. The rabbit pyrogen test (RPT), once the gold standard, has limitations that prompted the development of in vitro alternatives like the monocyte activation test (MAT). While MAT is validated and accepted in the EU, the United States, Russia, and India, only the European Pharmacopoeia has fully phased out RPT, making MAT compendial. In contrast, RPT remains the gold standard in the United States, reflecting regulatory inertia and global inconsistencies. This chapter analyzes the historical, scientific, and regulatory evolution of pyrogen testing, comparing Europe and the United States. It finds the United States lags in phasing out RPT, and that even in Europe, the transition took nearly 40 years. Proactive regulation and simultaneous method phase-in/out are essential to accelerate future transitions.
BT - Moving Toward Nonanimal Approaches in Medical Research and Testing
DA - 2027-01-01
N2 - Efforts to replace animal testing with human-relevant methods have advanced. Pyrogenicity quality control testing illustrates the progress of this transition well. The rabbit pyrogen test (RPT), once the gold standard, has limitations that prompted the development of in vitro alternatives like the monocyte activation test (MAT). While MAT is validated and accepted in the EU, the United States, Russia, and India, only the European Pharmacopoeia has fully phased out RPT, making MAT compendial. In contrast, RPT remains the gold standard in the United States, reflecting regulatory inertia and global inconsistencies. This chapter analyzes the historical, scientific, and regulatory evolution of pyrogen testing, comparing Europe and the United States. It finds the United States lags in phasing out RPT, and that even in Europe, the transition took nearly 40 years. Proactive regulation and simultaneous method phase-in/out are essential to accelerate future transitions.
PB - Academic Press
PY - 2027
SN - 978-0-443-26514-3
SP - 289
EP - 319
ST - Chapter 18 - Phasing out animal tests
T2 - Moving Toward Nonanimal Approaches in Medical Research and Testing
TI - Chapter 18 - Phasing out animal tests: An analysis of the successful transition from rabbits to human-relevant methods in Europe
UR - https://www.sciencedirect.com/science/article/pii/B9780443265143000175
Y2 - 2026-10-05
ER -