Cetero adds multi site transdermal trial capacity
Earlier this month, the US Food and Drug Administration (FDA) set out new guidance of the development of such technologies prompted by concerns about overdose risk associated with transdermal delivery patches.
While the recommendations focused on measures to curb the overfilling of patches, they also touched on the need to test such delivery technologies in a range of different climatic conditions to assess adhesive performance.
This was clearly a motivation for Cetero’s expansion, given that the contract research organisation (CRO) has added adhesion, irritation and sensitization (A/I/S) testing capacity at sites in Miami, St Louis and Toronto, Canada.
The firm said it has harmonized the training and specific study processes across the sites, adding that it “has successfully conducted A/I/S studies at these multiple sites using identical scoring and performance standards.”
Cetero's also suggested that the ability to use multiple sites as and when required “can ensure complete study enrolment” which, while a bold claim, would certainly be attractive to a drug industry keen to reduce development costs.
Preclinical growth
In addition to the clinical expansion, Cetero has also boosted its preclinical analytical capacity with the installation of two new LC/MS/MS systems at its laboratory in Fargo, North Dakota.
The firm, which already has LC/MS, LC/UV and GC/MS units at the facility, said the expansion adds to its "ability to conduct testing of in vitro percutaneous absorption and semi-solid release to GLP standards."
