New data strengthens case for microdosing in drug development

Preliminary results from the European Union Microdose AMS Partnership Programme (EUMAPP) further endorse the growing body of microdose data that predicts pharmacological dose ADME/PK outcomes, according to Xceleron, a global leader in predictive clinical research.

The EUMAPP consortium presented preliminary data from the 30-month, Euro 2m project at the European Federation for Pharmaceutical Sciences (EUFEPS) Conference in Germany. The compounds selected for EUMAPP were chosen to rigorously test the predictability of human microdosing by studying drugs that exhibited properties in humans that are difficult to predict in animal or in vitro models and drugs with properties that, it was suspected, might be difficult to predict at a therapeutic dose from microdose data.

EUMAPP is co-ordinated by Xceleron, of York in the UK, and funded by the European Commission. It comprises 10 organisations from five countries (UK, Sweden, the Netherlands, France and Poland). The aim is to evaluate microdosing for drug development and to arrive at recommendations about how and when it could and should be used.

"The outputs of the programme need to undergo rigorous scrutiny and detailed interpretation but the early indications are that results strongly endorse the ability of microdosing to provide valuable human data at the earliest stages of exploratory clinical development," said Dr Colin Garner, president and ceo of Xceleron and chair of the EUMAPP steering committee.

Professor Malcolm Rowland, scientific advisor to the EUMAPP consortium observed: "Generally the EUMAPP results are sufficiently encouraging to continue to support the view that, applied intelligently, microdosing coupled with AMS offers an additional tool to facilitate earlier than otherwise possible decisions in candidate selection."

Recently Xceleron announced that it has developed a database of 25 compounds with data on both microdose and pharmacological dose that show 80% predictability of pharmacokinetic parameters over dose ranges of a hundred-fold and more (in some cases many thousand-fold) for a diverse range of compounds.