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Sufficient Early ADME Profiling to Minimize Wasted Time and Expenditures

The development process of new therapeutics is one of several factors that directly impact the cost of healthcare today. Due to the amount of time and money involved, great efforts are being made to change the way drug candidates are processed, evaluated and selected. While certain processes were once approached as the next step of a sequence in a linear fashion, early ADME profiling employs a more proactive approach, so that avoidable issues that frequently arise in the development phase can be addressed earlier in the discovery phase, thereby mitigating the typically high failure rates of new chemical entities (NCEs) entering development for testing.

The assessment of a compound’s absorption, distribution, metabolism, and excretion (ADME) characteristics, as well as its toxicity and other such pharmacokinetic measurements, are important indicators of in vivo success. Genomics and combinatory chemistry are sometimes employed in order to counterbalance treatment targets that lack proof of concept in man, and to increase the number of drug candidates entering the pipeline. However, these approaches tend to create risky targets with weak pharmacokinetic properties. Early ADME assessment of candidates eliminates many of these compounds before this point of realization is reached.

Traditionally, the early discovery phase of identifying therapeutic targets leads finding and optimization, the NCE nomination focuses on in vitro efficacy, and the development phase follows and promotes candidates based on in vivo performance. A disconnect is created when in vivo assessments are made in products which are designed and tested in vitro.

Rather than the traditional sequential approach, integrating aspects of the discovery and development phases will allow researchers to characterize drug candidates from multiple angles from the start. Early ADME profiling helps researchers paint a complete picture of drug candidates as early as possible. Doing so can decrease the number of weak candidates that move on to the next phase of development and testing, so that the failure rate and wasted resources are greatly minimized.

As one can imagine, reorganizing a highly specialized infrastructure involves the adaptation of detailed processes and specialized equipment, to different timelines and modified purpose. However, progress continues and is very promising.

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Categories: Toxicology and Pharmacology

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