Absorption Systems' metabolism services encompass lead optimization through the IND- and NDA-enabling submission process. Our unique and customer-centric Data Concierge™ approach provides the knowledge and expertise to help work with your team and support their decision-making at every step along the way.
Metabolism is the enzymatic modification of drugs and other xenobiotics usually to increase clearance. It is a determinant of oral bioavailability, clearance and half-life in vivo. Metabolism occurs predominantly in the liver and may also occur in the intestine or other organs.
Evaluation of an NME's drug-drug interaction potential is an integral part of drug development and regulatory review prior to market approval. Many metabolic routes of elimination, including most of those occurring through the cytochrome P450 family of enzymes, can be inhibited or induced by concomitant drug treatment. Observed changes arising from metabolic drug-drug interactions can be substantial — an order of magnitude or more decrease or increase in the blood or tissue concentrations of a drug or metabolite — and can include increased formation of toxic and/or active metabolites or elevated exposure to a toxic parent compound such that toxic levels are achieved. For this reason, in vitro metabolic assessment plays a key role in early drug discovery with ExpressPlus™ screening assays as well as in advanced stages of development.
Learn more about predicting human hepatic clearance.
Learn more about drug metabolism discovery tools and methods.
Learn more about drug metabolism testing for IND-enabling submissions.
Learn more about metabolism NDA-enabling tools and methods.
Learn more about metabolite ID services.
Learn more about metabolism testing for drug-drug interactions.
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