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ADME Development Services

Discover why Invitrogen is a leading provider of ADME in vitro screening and development programs.  We offer standardized and custom programs, led by an experienced PhD-level scientific staff, backed up by processes that deliver fast cycle times.

Cytochrome P450 Induction

  Determine if your drug compound increases the formation of toxic metabolites and/or decreases the systemic levels of a co-administered drug with the use of Invitrogen’s CYP450 Induction Services.  Our studies utilize our primary hepatocytes to monitor levels of CYP protein and mRNA upon exposure to your new chemical entity (NCE).  Relative potency of your NCE is compared against positive controls in accordance with the US FDA’s guidance on drug-drug interactions.

Cytochrome P450 Inhibition

  Prepare for your compound’s IND submission with data generated from Invitrogen’s CYP450 Inhibition Services.  Using a pool of GLP-validated human liver microsomes, we determine if your new chemical entity (NCE) has the potential to inhibit CYP450 enzymes, which in turn could decrease the metabolic clearance of a co-administered drug.  Our development protocols include the determination of IC50 based on metabolite formation and follow US FDA recommendations.

Metabolic Stability & Profiling

  Use Invitrogen’s Metabolic Stability and Profiling Services to determine your drug candidate’s metabolic half-life, intrinsic clearance rates, and major metabolites in liver microsomes or hepatocytes.  Results from this in vitro service will help guide the design of your in vivo preclinical studies, including a dosing regimen and species selection.

Plasma Protein Binding

  Assess the extent of non-specific binding between your new chemical entity (NCE) and human and animal plasma proteins with Invitrogen’s Plasma Protein Binding Services.  We use equilibrium dialysis to determine your compound’s protein binding percentage, which is a reflection of its clearance rate, efficacy, and potential for drug-drug interactions.

p-GP and Other Hepatic Transporters

  Discover if your compound is a substrate or inhibitor of the multi-drug resistant protein P-gp (MDR1), an efflux transporter frequently involved in drug interactions, using Hepatic Transporter Services from Invitrogen.  We follow FDA-designed development protocols using Caco-2 cells or MDCK cells transfected with human P-pg.

B-CLEAR® services, which evaluates transporters as a system in hepatocyte models, is available to our North American customers through a licensing agreement with Qualyst.

qNPA™ Gene Expression Studies

  Gain insight into your compound’s impact on liver function using hepatocyte-based Gene Expression Services from Invitrogen.  We simultaneously monitor mRNA levels of 14 toxicologically and pharmacologically relevant gene targets, allowing you to rank compounds according to their potencies (EC50) and develop hypotheses around mode of action.