Azopharma adds microdosing to service portfolio

By Phil Taylor

- Last updated on GMT

Related tags: Pharmacology, Mass spectrometry

Contract drug development company Azopharma Product Development has set up a new business unit to cater for companies wanting to run microdosing or so-called Phase 0 studies.

The company said it will provide services to synthesise materials for use in microdose studies, formulate and administer microdoses in clinical trials, and carry out sample analysis. Microdosing involves the use of accelerator mass spectroscopy (AMS) to count radioactive carbon atoms (14C) in blood, urine and or faecal samples from volunteers who have taken radiolabelled doses of test compounds.

The aim is to predict pharmacological dose absorption, metabolism, distribution and elimination (ADME) and pharmacokinetic (PK) while using a subtherapeutic dose of the active ingredient. That is a safer approach for patients but still provides valuable pharmacological data that cannot be generated in animal research, according to Azopharma.

Supporters of microdosing studies claim they can identify compounds likely to fail earlier, preventing wasted investment of time and resources, as a proportion of these failures can be attributed to poor PK data. That in turn can point to potential efficacy or safety issues in humans.

Microdosing is important among pharmaceutical and regulatory agencies and enables the industry to save time and money on development processes by receiving early PK and ADME data in humans,​” said Azopharma in a statement.

The technique has been pioneered by the likes of Xceleron and Pharmaceutical Profiles, which have steadily been building evidence of the value of the approach. Earlier this week Pharmaceutical profiles reported the successful use of a microdosing approach in the study of an HIV therapeutic, while back in June Xceleron and partners in the European Union Microdose AMS Partnership Programme published preliminary results of a study endorsing the value of the approach and of AMS as a means to obtain results.

Another player in microdosing is Covance, which has been developing a ‘cold’ approach that uses ultra-sensitive accelerator mass spectrometry and does away with the need for radiolabelling of compounds. That makes formulation of the materials quicker and easier.Phil Meeks, CEO of Azopharma, said: “This new service is a natural extension of our current business model. We are already a leader in the formulation and clinical trial fields. This gives our clients a new option in their development process​.”

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