AXIS Clinicals US Expands Capabilities to Conduct hADME Studies for NDA and 505(b)(2) Filings
AXIS Clinicals
Dec. 20, 2024
DILWORTH, Minn., Dec. 20, 2024—AXIS Clinicals US is pleased to announce the award of a Radioactive Materials License (RAM License) issued from the Minnesota Department of Health which permits the handling of radioactive materials. This license, along with the creation of extensive SOPs and staff training programs has opened the door to performing humanADME (hADME) studies for NDA and 505(b)(2) filings.
AXIS is delighted to add hADME studies to their early clinical pharmacology capabilities which include First-In-Human, Single Ascending Dose, Multiple Ascending Dose, Cardiac Safety TQT, Food Effect, Drug-Drug Interactions, and PK/PD.
Dr. Pete Boldingh, (Vice President, Clinical Operations) said, “By adding the ability to perform hADME studies at our Minnesota facilities, AXIS is capable of supporting full clinical pharmacology programs for our clients.”
Industry leaders from various private and government organizations assisted in the training of AXIS staff to ensure successful implementation of FDA protocols in hADME studies. These trainings were integral to the creation of the necessary SOPs to perform these studies in a safe and effective manner.
hADME studies at AXIS will maximize the potential of breakthrough drug development. AXIS’ hADME team will see these studies through the initial development of the program design, selection of study candidates, and all the way to development and regulatory approval.
AXIS is proud to open the doors to pharmaceutical and biotech sponsors in need of efficient and meaningful drug-development journeys. Please contact John Pottier, Senior Vice President of Business Development with any questions concerning AXIS Clinicals’ capabilities.
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About AXIS Clinicals
AXIS Clinicals is the leading clinical and bioanalytical pharmacology research organization conducting studies in healthy volunteers and targeted populations.
AXIS Clinicals Contact
John Pottier | Senior Vice President, Business Development
+1 (913) 314-6755
j.pottier@axisclinicals.com
axisclinicalsusa.com