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The importance of in vitro ADME: implementing high-quality assays to assess ADME properties, at a throughput that matches the project demand for decision-making data, can be a tricky business. Outsourcing to a CRO may be the solution.

In vitro tests to assess the likely absorption, distribution, metabolism and excretion (ADME) characteristics of new molecules are important tools in the early stages of drug discovery and help ensure appropriate in vivo pharmacokinetic behaviour in compounds reaching the clinic. These ADME assays provide companies with vital information for the selection of appropriate candidates or early termination of less promising projects, maintaining efficiency and reducing the risk of expensive late-stage failures.

An Intelligent Approach to Testing

During the past 15 or more years, the availability of relatively high-throughput ADME assays has generated vast amounts of data within large pharmaceutical companies, but with little improvement in success rates. Many assays have been performed on compounds that were unlikely to make the grade, particularly during the period when combinatorial chemistry approaches were in vogue. Consequently, companies are returning to a more rational and selective approach to ADME testing, whereby appropriate screens for a particular therapeutic target are selected from the available bank of in vitro tests; that is, customized ADME screening cascades rather than a blanket screening approach.

Maintaining a wide selection of screens, each with an unpredictable level of throughput, however, can be difficult in the structured programme environment of a large pharmaceutical organization. Hence, outsourcing is increasingly seen as a way of achieving this flexibility and efficiency. Certain expert contract research organizations (CROs) have a wealth of ADME experience and expertise, and can adapt and tailor their services to meet the client's needs and, as these can be called upon as required, can be an effective way to control costs.

The spectrum of ADME assays is ever increasing, as the factors controlling drug disposition are better understood. Outsourcing the routine ADME assays can free up a company's in-house resource to develop those new assays that are important to their project. Once established, these can then be run on a routine basis at a CRO, again freeing up the in-house resource. Other companies prefer to run routine assays through their optimized in-house protocols and use the CRO experience to develop custom or project-specific methods. For smaller organizations, outsourcing to CROs gives them access to extensive practical ADME resource and to a valuable source of experience and knowledge to help interpret data and make recommendations for compound progression.


The primary goal of an in vitro ADME laboratory is to implement high-quality assays to assess those ADME properties that are key to the success of a specific project, at a throughput that matches the project demand for decision-making data. CROs offer pharma and biotech companies a high-quality and flexible ADME service, backed by considerable experience and expertise. Larger companies may outsource the more routine aspects of the process, freeing up the in-house ADME team to work on more complex issues, whereas a smaller company can take advantage of the CRO's extensive ADME testing resources and experience, to develop custom or project-specific methods. Whatever a company's requirement from ADME, outsourcing to a CRO can provide the solution.


For more information

Dr Alan Beresford

Senior Research Fellow, ADMET

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Title Annotation:DRUG DISCOVERY; absorption, distribution, metabolism and excretion, contract research organizations
Author:Beresford, Alan
Geographic Code:1USA
Date:Jul 1, 2010
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