Validating stability and selectivity in the presence of co-administered compounds

DeChenne S, Yahvah K, Zimmer J | Bioanalysis, 11(20), 1819–1821 (2019)

Keywords: co-administered compound • co-administered drug • guidance • selectivity • stability • validation

“We would agree with an often stated industry perspective that co-administration stability testing should only be required when the PK profile of the drug that is assessed is a primary end point of the study being performed.”

This journal article from Bioanalysis takes a look at how CROs, pharmaceutical companies and regulators have tackled the issue of co-administered stability, including whether co-administered drugs impact analyte stability and the regulatory requirements needed for cases of co-administered drugs.

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