| By Azopharma Product Development Group - HOLLYWOOD, F |
| Monday, 03 November 2008 |
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Azopharma Product Development GroupTM is pleased to announce its entrance into the Microdosing market. Azopharma will provide services to synthesize material amenable to microdose studies as well as formulate, administer microdoses in a clinical environment and analyze samples. Microdosing is an important growing
trend among |
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pharmaceutical and regulatory agencies around the world. This technology enables the pharmaceutical
industry to save both time and money on their development process by receiving early PK and ADME data in humans.
Microdosing involves the use of radiolabeled materials at very low levels. Typically patients are dosed at 1/100 of the
anticipated therapeutic dose. Samples are then analyzed with a specialized instrument called an Accelerator Mass
Spectrometer (AMS) which is capable of detecting the labeled compound at 10-21 mole levels. The extremely low dose
levels minimize potential toxicological effects in humans while providing valuable pharmacological data which may
not be found in animal research.
Mr. Phil Meeks, CEO of Azopharma Product Development Group says, “This new service is a natural extension of our
current business model. |
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We are already a leader in the formulation and clinical trial fields. This gives our clients a
new option in their development process.” Mr. Meeks continues, “Due to the improved safety and potential gains in
development timelines, we foresee this technology becoming a key part of the drug development process.”
Azopharma Product Development Group brings together the best scientists in the field, state-of-the-art facilities and a
focus on quality that provides client partners an unbeatable combination in total product development.
Azopharma Product Development Group Includes :
• Azopharma Contract Pharma- ceutical Services - Integrated product development and CTM manufacturing
for all dosage forms.
• ApiCross Drug Delivery Technologies - Proprietary drug delivery platforms to solve difficult molecular
challenges.
• Cyanta Analytical Laboratories - Analytical chemistry and inhalation services from development to quality
control testing.
• AniClin Preclinical Services - Preclinical services in support of early product development.
• IQsynthesis - Synthetic chemistry services from discovery to clinical API supplies including large scale API synthesis.
• AvivoClin Clinical Services - Human |
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clinical pharmacology services for Phase I/II/III clinical trials
• ADMEQuant Bioanalytical Services - Bioanalytical research analysis of pharmaceutical compounds in all
matrices.
• Acromon Clinical Research Organization- Clinical monitoring, data management and statistical services.
About Azopharma
Azopharma Product Development Group, The Total Product Development Company TM, is FDA registered, DEA
approved and client audited on a regular basis. In product development, it comes down to the right people, their
commitment and application of experience.
Partnering with Azopharma provides customers with the confidence of
assured success. We welcome visits to our South Florida facilities as well as our other sites to conduct audits or meet
with our pharmaceutical scientists to outline a study that meets your specific needs. Contact one of our scientists at
development@azopdogroup.com or 954-433-7480.
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