Biological Information

Background Information:

Metabolic profiling of therapeutic compounds at early stages in the drug discovery process is of increasing importance. Drugs that undergo metabolism in vivo may produce pharmacologically-active or chemically reactive metabolites which can produce unexpected effects or potential toxicities. The recent FDA Guidance for Industry on Safety Testing of Drug Metabolites highlights the relevance of in vitro metabolite profiling early in drug development, as metabolites which are unique to or disproportionate in humans may require additional toxicological studies. In addition to the extensive panel of in vitro metabolism screening assays, Eurofins is able to perform studies using state-of-the-art MS instrumentation to thoroughly characterize the metabolic products of a drug compound in vivo or in vitro and compare metabolic profiles across species.

Organism:

Mouse

Construct Details:

Microsomes

Tissue:

Liver

Assay Information

Assay Type:

Biochemical

Assay Sub Type:

Enzymatic

Detection Method:

HPLC-MS/MS

Platform:

Xevo® G2 QTof

Measured Response:

Peak Area Response

Testing Information

Substrate:

Test compound

Test Sample Requirements:

Minimum for 1) Screen: 100 μl of 10 mM stock -OR- 1 to 2 mg (pre-weighed). 2) Dose Response: 250 μl of 10 mM stock -OR- 1.5 to 2 mg (pre-weighed).

Turnaround Time

Standard:

15 Business Days

Additional Information

Brand:

Cerep

Testing Location:

USA - St Charles, MO

Other Information:

Client to provide compound chemical structure to Client Services prior to study initiation for Metabolite ID services. If client does not have Intrinsic Clearance data on the requested compound, then the client will need to run Intrinsic Clearance in the corresponding matrix prior to the initiation of the Metabolite ID study.