On April 24, 2017
AAPS National Biotechnology Conference
On May 1-3, 2017
Drug Metabolism Assays
MicroConstants can determine the stability of a test article in a variety of enzyme sources. Hepatocytes, liver microsomal preparations, and plasma are the most common, though many others are available. The time points are customized for each project, and the deliverables include raw data, percent remaining, and half-life values.
Metabolite Profiling & Identification
We are able to generate and compare metabolite profiles to assist with species selection for toxicology studies or to evaluate circulating metabolites. These studies are performed using accurate mass spectrometry (QTof Premier) to analyze samples from metabolic stability assays or in-life dosing studies. We search the data sets for potential metabolites and compare the time profiles of parent compound loss and metabolite formation. The profiles can be used to find unique or disproportionate human metabolites. When possible, identities of metabolites are proposed based on accurate mass data and product ion spectra. A metabolite standard may also be supplied for comparison of the retention time and product ion spectra with those of the postulated metabolite.
Drug-Drug Interaction Studies
MicroConstants offers a range of services to evaluate the potential for drug-drug interactions, including cytochrome P450 (CYP450) induction studies, CYP/UGT inhibition studies, and CYP/UGT reaction phenotyping. These studies can be performed in a screening mode or in compliance with regulatory guidance documents from the FDA, EMA or PMDA.
Protein Binding Assays
We provide assays to determine the percentage of drug bound to plasma proteins using three different methodologies: equilibrium dialysis, ultrafiltration and ultracentrifugation. Studies can be designed to screen many compounds at once, or a pilot study and calibration standards can be used to provide definitive binding data suitable for inclusion in regulatory documents.