Fortrea, Emery Pharma Team Up On Rifampin Safety Testing For Clinical Trials
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.
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The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: the effects of each of Endo's and Mallinckrodt's recent emergences from bankruptcy; satisfaction of, and compliance with, regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; changes in market demand; issues with product quality, manufacturing or supply, or patient safety issues or adverse side effects or adverse reactions associated with XIAFLEX; and other risks identified and described in more detail in the 'Risk Factors' and 'Management's Discussion and Analysis of Financial Condition and Results of Operations' sections of Mallinckrodt's and Endo's most recent Annual Reports on Form 10-K, Mallinckrodt's Registration Statement on Form S-4, as amended, and other filings with the SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and we do not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law. * Most eligible patients with commercial insurance plans should pay a $0 copay for XIAFLEX. Predictions based on historical analysis of claims filed September 2022 through August 2023. References Hellstrom WJ. Int J Impot Res. 2003;15:S91-S92. Stuntz M, Perlaky A, des Vignes F, et al. PLoS One. 2016;11(2):e0150157. DiBenedetti DB, Nguyen D, Zografoset L, et al. Adv Urol. 2011:282503. ### Logo – View original content:
