accelerator mass spectrometry

/Tag:accelerator mass spectrometry

The Best Model for Humans is Human — How to Accelerate Early Drug Development Safely

Mark Seymour

Traditionally, the choice of which candidate compounds to take forward into development has been based on pre-clinical data. However, lack of predictivity of the human clinical situation in the models used has led to poor decision-making, and the later in the development process that such mistakes are realised, the more costly and time-consuming it is to correct them. Furthermore, compounds that may have made perfectly good drugs, have been dropped due to poor pharmacokinetics in animal models. Accelerator mass spectrometry (AMS) is an ultra-sensitive detection technique that can be used to quantify carbon-14. By administering very small amounts of 14C-labelled compounds, AMS can be used to obtain human clinical data very early in the drug development process. Such studies: a) can be helpful in understanding human pharmacokinetics using microdosing; b) can provide early human metabolism information, to validate the choice of animal species used in pre-clinical safety testing and identify unique or disproportionate human metabolites during Phase 1; and c) can provide fundamental human pharmacokinetic data, including absolute bioavailability, by facilitating a scientifically optimal and cost-effective study design. The provision of these clinical insights at the earliest possible opportunity can lead to improved decision-making, and therefore can reduce the time and cost involved in the drug development process.
You need to register (for free) to download this article. Please log in/register here.

Accelerating Clinical Insights: How to Use Accelerator Mass Spectrometry to Make Better Early Development Decisions

Mark Seymour

This paper is an overview of the applications of the technique of Accelerator Mass Spectrometry (AMS) in the biomedical drug development field. The work described here has been carried out at Xceleron (York, UK and Germantown, MD, USA), and it aims to apply AMS to provide better information about the human pharmacokinetic/metabolic behaviour of drugs or drug candidates as early as possible. It is hoped that the use of this technique will contribute to the delivery of better, more effective drugs onto the market sooner, which will be good news for all concerned.
You need to register (for free) to download this article. Please log in/register here.