Скачать или смотреть Restoring Rifampin: Fortrea & Emery Pharma’s Partnership for Safer DDI Studies & Nitrosamine Testing

Nitrosamine Risk & Rifampin: Fortrea + Emery Pharma Break Down the New FDA Guidance


In this exclusive 8-minute conversation, we sit down with Marcus Stavchansky, Pharm.D. of Fortrea and Ryan Cheu, Ph.D. and Chris Purcell of Emery Pharma to unpack the FDA’s evolving guidance on nitrosamines—specifically the acceptable intake (AI) limits of 1-methyl-4-nitrosopiperazine (MNP) in rifampin, a critical CYP3A4 inducer for drug-drug interaction (DDI) studies.

🎧 Topics discussed include:
• Why rifampin was nearly shelved—and what brought it back
• How Emery Pharma ensures MNP levels are below FDA limits
• What Fortrea is doing to integrate validated lots into DDI protocols
• Why this matters for your IND-enabling studies and regulatory filings

This strategic collaboration empowers drug developers to move forward with rifampin-based DDI studies confidently, without compromising on safety, compliance, or timelines.

👇 Watch now to hear what this means for the future of early-phase clinical development.

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🔬 #Nitrosamines #Rifampin #DDIstudies #FDACompliance #PharmaceuticalTesting #EmeryPharma #Fortrea #Bioanalysis #DrugDevelopment #ClinicalTrials #CYP3A4 #MNPtesting #PharmaRegulations #CDMO #CRO #PharmaceuticalIndustry #MassSpectrometry #AnalyticalChemistry #GLP #GMP #RegulatoryScience

About Emery Pharma:
Emery Pharma is deeply committed to advancing public health and exclusively focuses on projects that enhance the well-being of both individuals and the environment. As a comprehensive contract research laboratory, Emery Pharma provides extensive support across the entire spectrum of pharmaceutical development, covering small molecule drugs, biologics, biosimilars, gene therapy, botanicals, and more.

Emery Pharma's array of premium services includes analytical and bioanalytical solutions, microbiology and cell biology services, drug and impurity characterization, and comprehensive R&D with cGMP/GLP support. The Emery Pharma team excels in customizing innovative solutions tailored to the unique requirements of each client. They seamlessly oversee the entire process, from initial drug discovery to thorough data analysis and insights generation. Their expertise allows them to tackle scientific challenges proactively, ensuring clients avoid unnecessary setbacks.

Emery Pharma's accomplished chemists and biologists harness state-of-the-art technology, encompassing cutting-edge tools such as high-resolution mass spectrometry (Orbitrap), triple quad LC-MS/MS, GC-MS, preparative HPLC, and 400 MHz multinuclear NMR.

For further details, please don't hesitate to reach out to Emery Pharma at [email protected] or explore their website at:
https://emerypharma.com/