Early-stage contract research organisation Cetero Research has expanded its Clinical Dermatology and Transdermal Drug Delivery System (TDDS) services to four of its clinical facilities in the US and Canada, in line with recent Food and Drug Administration guidance.
The US company can now conduct multi-site clinical dermatology and TDDS studies for adhesion, irritation and sensitisation (A/I/S) trials across its facilities in Miami, Florida, St Louis, Missouri and Toronto, Ontario in addition to its Fargo, North Dakota site.
Moreover, Cetero has increased the sophistication of its preclinical analytical capabilities with more sensitive, highly advanced equipment, the company notes.
Specifically, its Pre-Clinical Dermatology Research Laboratory has added two MicroMass LC/MS/MS (liquid chromatography/ tandem mass spectrometry) systems to complement its current four LC/MS and four LC/UV (liquid chromatography/ultraviolet) and GC/MS (gas chromatography/mass spectrometry) systems.
The LC/MS/MS systems provide “the additional level of analytical sensitivity and selectivity needed to evaluate the in vitro dermal absorption of the most challenging compounds currently in development or production”, the company says.
Explaining the expansion of its dermatology/TDDS services, Cetero points out that recent US FDA guidance for transdermal delivery systems recommends using at least two study sites with different climates to assess patch adhesion performance as well as irritation and sensitisation potential.
The company “has harmonised the personnel training and specific study processes across the four clinical sites, and has successfully conducted A/I/S studies at these multiple sites using identical scoring and performance standards, with the same protocol and comprehensive final report within one full-service package”, it says.
The “multi-site, one-CRO advantage” also extends to special population needs, such as enrolling post-menopausal women, Cetero adds.
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