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ECVAM and pharmaceuticals.

Philippe Vanparys¹

¹Department of Genetic and In Vitro Toxicology, Johnson & Johnson Pharmaceutical Research & Development (a Division of Janssen Pharmaceutica NV), Turnhoutseweg 30, 2340 Beerse, Belgium.

Alternatives to Laboratory Animals : ATLA

|January 7, 2003

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New medium-throughput absorption, distribution, metabolism, and excretion (ADME) and toxicity tests are needed to speed up drug development. These methods will improve candidate selection, reduce costs, and decrease animal testing.

Area of Science:

Pharmaceutical Science
Toxicology
Drug Discovery

Background:

Conventional toxicology testing occurs late in drug development, creating a bottleneck.
High-throughput screening has increased the number of drug candidates, exacerbating throughput limitations.
Existing safety tests are low-throughput, hindering efficient drug development.

Purpose of the Study:

To address the bottleneck in drug development caused by low-throughput safety testing.
To introduce the need for new, down-scaled, in vitro test models for ADME and toxicology.
To highlight the benefits of medium-throughput testing for early-stage drug candidates.

Main Methods:

Implementation of high-throughput screening in the Discovery phase.
Development of down-scaled in vitro test models.

Related Experiment Videos

Transition to medium-throughput absorption, distribution, metabolism, and excretion (ADME) and toxicity assays.

Main Results:

Increased number of lead candidates from high-throughput screening.
Identification of low throughput of conventional safety tests as a bottleneck.
Potential for medium-throughput tests to enhance selection of safer new chemical entities.

Conclusions:

Medium-throughput ADME and toxicity tests are crucial for the late-Discovery and early-Development phases.
Adopting these tests will reduce resource use and development time.
This strategy significantly decreases the need for animal testing in drug development.