Core Insights - Fortrea has established a strategic partnership with Emery Pharma to support the detection of nitrosamine impurities, specifically 1-methyl-4-nitrosopiperazine (MNP), in the drug rifampicin for drug-drug interaction (DDI) studies [1][2] - The collaboration aims to ensure that impurity levels remain below the acceptable intake limits set by the FDA, thereby enhancing the safety and efficacy of clinical trials [1][2] Group 1: Partnership Details - Fortrea selected Emery Pharma due to its strong capabilities in analytical and bioanalytical testing, which will support Fortrea's global clinical projects [2] - The partnership allows sponsors to utilize rifampicin for DDI assessments, leveraging its excellent safety and tolerability profile [2] - The collaboration is expected to reduce early trial risks, accelerate trial timelines, and improve data quality [2] Group 2: Impurity Detection and Regulatory Compliance - The new impurity detection level for rifampicin is now available for Fortrea's clients conducting clinical pharmacology trials, designed to be flexible and compliant with FDA requirements [3] - The FDA previously identified that all tested batches of rifampicin exceeded acceptable MNP levels, prompting researchers to seek alternative drugs, which posed safety risks [2] - In 2023, the FDA updated guidelines, raising the acceptable limits for MNP in rifampicin [2] Group 3: Company Backgrounds - Fortrea is a leading global clinical development solutions provider, collaborating with biopharmaceutical, biotechnology, medical device, and diagnostic companies to expedite medical innovations [4] - Emery Pharma is recognized for its scientific leadership in impurity analysis and regulatory compliance, focusing on GLP and cGMP analytical testing [5][6] - Emery Pharma specializes in developing and validating sensitive and specific analytical methods for nitrosamine detection, playing a crucial role in helping pharmaceutical sponsors navigate evolving FDA and ICH guidelines [5][6]