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SERVICES - Adverse Drug Effects Assay
IVAL’s Human Hepatocyte Adverse Drug Effects (ADE) Assay addresses the most critical questions in drug development such as:
Hepatotoxicity: The liver is a major target organ of drug toxicity. Hepatotoxicity is a major cause of clinical trial failure and market withdrawal.
CYP3A inhibition: CYP3A4 is the most abundant P450 isoform, with many existing drugs as substrates. A drug candidate with CYP3A4 inhibitory potential is highly undesirable due to its drug-drug interaction potential. Inhibition of CYP3A could cause decreased metabolic clearance of CYP3A4 substrates, resulting in toxic plasma concentration levels.
CYP3A induction: CYP3A is also a highly inducible P450 isoform. CYP3A induction will lead to accelerated metabolic elimination of its drug substrates. Accelerated metabolic clearance could lead to a lower than desired plasma concentration, resulting in therapeutic failure.
The ADE Assay employs human hepatocytes, the GOLD standard for ADME-tox studies. Moreover, three endpoints: in vitro hepatotoxicity; CYP3A inhibition, CYP3A induction are evaluated to deliver results to you as early as 2 weeks from chemical receipt to keep up with the pace of your projects.
You will receive a report containing results of the following:
1. Results from 11 test article concentrations;
2. Statistical analysis of triplicate determinations;
3. Comparison of test article results with positive and negative controls
IVAL’s ADE Assay is currently offered at a highly competitive introductory price. Please contact us for sample protocol and pricing.
Hepatotoxicity: The liver is a major target organ of drug toxicity. Hepatotoxicity is a major cause of clinical trial failure and market withdrawal.
CYP3A inhibition: CYP3A4 is the most abundant P450 isoform, with many existing drugs as substrates. A drug candidate with CYP3A4 inhibitory potential is highly undesirable due to its drug-drug interaction potential. Inhibition of CYP3A could cause decreased metabolic clearance of CYP3A4 substrates, resulting in toxic plasma concentration levels.
CYP3A induction: CYP3A is also a highly inducible P450 isoform. CYP3A induction will lead to accelerated metabolic elimination of its drug substrates. Accelerated metabolic clearance could lead to a lower than desired plasma concentration, resulting in therapeutic failure.
The ADE Assay employs human hepatocytes, the GOLD standard for ADME-tox studies. Moreover, three endpoints: in vitro hepatotoxicity; CYP3A inhibition, CYP3A induction are evaluated to deliver results to you as early as 2 weeks from chemical receipt to keep up with the pace of your projects.
You will receive a report containing results of the following:
1. Results from 11 test article concentrations;
2. Statistical analysis of triplicate determinations;
3. Comparison of test article results with positive and negative controls
IVAL’s ADE Assay is currently offered at a highly competitive introductory price. Please contact us for sample protocol and pricing.
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Copyright 2009 In Vitro Admet Laboratories I 9221 Rumsey Road Suite 8 I Columbia, MD 21045 I Tel: (410) 869-9037 Fax: (410) 869-9034 I Email: info@invitroadmet.com