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Fortrea, Emery Pharma Team Up On Rifampin Safety Testing For Clinical Trials
BUSINESS
KUALA LUMPUR, June 25 (Bernama) -- Fortrea, a global contract research organisation (CRO), has announced a strategic collaboration with Emery Pharma to provide rapid impurity testing of rifampin used in drug-drug interaction (DDI) studies.
In a statement, Fortrea said the partnership will enable testing for 1-methyl-4-nitrosopiperazine (MNP), a nitrosamine impurity, ensuring levels remain below the acceptable intake limit set by the United States Food and Drug Administration (FDA).
Fortrea Chief Medical Officer and President of Clinical Pharmacology Services, Dr Oren Cohen said the partnership would help accelerate early-phase clinical trials by providing certified rifampin for use in DDI studies and enhance data quality.
'This collaboration reflects our shared commitment to smarter study design and greater participant safety,' he said.
Meanwhile, Emery Pharma Chief Executive Officer, Dr Ron Najafi said the collaboration would contribute to safer and more efficient drug development, adding that the company specialises in solving complex analytical challenges in compliance with regulatory standards.
Fortrea selected Emery Pharma based on its expertise in analytical and bioanalytical testing under current Good Manufacturing Practice (cGMP) and Good Laboratory Practice (GLP) standards.
The new testing service is now available to Fortrea customers involved in clinical pharmacology trials, with study designs tailored to FDA requirements.
Rifampin, a widely used antibiotic and a preferred agent in DDI studies due to its safety and tolerability, had previously come under scrutiny after the FDA found that MNP levels in tested batches exceeded acceptable limits.
However, the agency revised its guidance in 2023, allowing the continued use of rifampin under updated thresholds.
