Drug metabolism and drug transport are major determinants of drug clearance, interindividual pharmacokinetic differences, clinical efficacy, and toxicity of drugs. Inappropriate pharmacokinetics can result in inadequate pharmacodynamic action and/or extremely wide variations in clinical response leading to failure of new chemical entities in drug development in man. Hepatic metabolism of drugs as well as their interactions with hepatic transporters may cause toxicity and contribute to the variability between individuals in susceptibility to such adverse drug reactions. Therefore, key issues in the early phase of drug discovery and development include not only an exhaustive characterization of pharmacological activity, but also investigation of metabolic stability, metabolite profiles, major metabolic routes involved in metabolite formation, the enzymes involved, and the potential for enzyme inhibition or induction.

KaLy-Cell and CiToxLab have joined forces to provide researchers ex vivo and in vitro preclinical metabolism studies with xenobiotics in various species

 

KaLy-Cell scientists have extensive experience in hepatocyte isolation, cryopreservation and culturing as well as in vitro and ex vivo ADME-Tox assays.

CiToxLab scientists have extensive experience in analytics an in vitro and ex vivo ADME-Tox assays.

By combining our expertise in cell and molecular biology, mechanistic toxicology and analytics, we provide incomparable evaluation of drug candidates for mechanisms of toxicity, drug-drug interactions and safety assessments as recommended by the FDA.

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