Fortrea: Fortrea a global contract research organization, has announced a strategic collaboration with Emery Pharma.
According to BERNAMA News Agency, this partnership aims to deliver FDA-compliant drug-drug interaction studies using rifampin, a drug frequently used in such studies due to its safety and tolerability.
Fortrea has selected Emery Pharma for its strong capabilities in analytical and bioanalytical testing, which will support Fortrea’s global clinical programs. Emery Pharma, known for its testing services under current Good Manufacturing Practice (cGMP) and Good Laboratory Practice (GLP), will provide rapid lot-by-lot testing of 1-methyl-4-nitrosopiperazine (MNP) in rifampin. This testing ensures that impurities remain below the Acceptable Intake (AI) Limit set by U.S. Food and Drug Administration (FDA) guidelines.
The collaboration enables sponsors to conduct drug-drug interaction assessments using rifampin as an agent for inducing the CYP3A4 isoenzyme. This development offers a reliable and compliant means of conducting these essential studies, reinforcing the role of rifampin as a preferred agent.