The assessment of pharmacokinetic (PK) based drug-drug interactions (DDI) is now an essential element of drug development. As populations expand and individuals live longer, patients are increasingly prescribed multiple concurrent medications (polypharmacy). Consequently the risk of adverse drug reactions due to DDIs is also increasing and leading to heightened regulatory scrutiny. New drugs with a high DDI potential may be at risk of non-approval or withdrawal.
To manage and help minimize this increasing risk, the major regulatory authorities (FDA, EMA, JMHLW) have published recent guidance(s) advising sponsoring companies on assessing the DDI ‘liabilities/risks’ of their new drug candidates.
Envigo has over 40 years’ experience assessing new drugs for their DDI liability/risk and helping customers with DDI studies that have been submitted to, and accepted by, regulatory authorities across the world.
Envigo offers an integrated DDI Assessment Program which includes all the studies necessary for complete DDI assessment in vitro. Our program is designed to deliver all (or just one) of the above studies, first time, on time.
Envigo offers a full range of GLP-compliant in vitro assays (basic models) designed to assess drug status/liability as both a victim and a perpetrator drug.
DDI assessment as victim drug (substrate interactions):
• CYP phenotyping
• UGT phenotyping
• Efflux drug transporter phenotyping
• Uptake drug transporter phenotyping
DDI assessment as perpetrator drug (inhibition and induction interactions):
• CYP inhibition (including TDI/MBI)
• UGT inhibition
• CYP induction (Emax)
• Efflux drug transporter inhibition
• Uptake drug transporter inhibition