High throughput (HT) Absorption, Distribution, Metabolism, and Excretion (ADME) screening technology is the current push from Big Pharma to be outsourced through contract research organizations (CROs). Shifting also is the ADME regulatory emphasis; the FDA has released a draft guidance (17 Feb 2012) that includes specific wording around what needs to be done with respect to transporter drug-drug interactions (both efflux and influx). The guidance will start to drive significant changes in how ADME screening is performed. Two assays that are routinely being utilized in pharma are the Caco-2 cell-based assay and the PAMPA (parallel artificial-membrane permeation) assay. As currently practiced, predictive ADME screening is made even more difficult given the variety of transport mechanisms available. In toxicology screens (ADME-tox), however, one is not looking for altered aspects of the drug, which is generally initially unknown, but changes in known, endogenous parameters. Thus ADME-tox lends itself more easily to HT platforms. New platforms for high throughput ADME screening are available, and discussed in this article.
Source: Drug Discovery and Development