Azopharma to Provide Microdosing Services

Azopharma Product Development Group has entered the microdosing market and will provide services to synthesize material open to microdose studies as well as formulate and administer microdoses in a clinical setting, and analyze samples.
   
Microdosing involves the use of radiolabeled materials at very low levels where patients are dosed at 1/100 of the anticipated therapeutic dose. Samples are then analyzed with an Accelerate Mass Spectrometer (AMS), which is capable of detecting the labeled compound at 10-21 mole levels. The extremely low dose levels minimize potential toxic effects in humans while providing pharmacological data, which may not be found in animal research. 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.
   
Phil Meeks, chief executive officer of Azopharma Product Development Group 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. Due to the improved safety and potential gains in development timelines, we foresee this technology becoming a key part of the drug development process.”