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announced the expansion of multiple Clinical Dermatology and Transdermal Delivery System (TDDS) services to four Cetero clinical facilities. Cetero has also enhanced the sophistication of its preclinical analytical capabilities with more sensitive, advanced equipment.
"There are very unique complexities surrounding topical and transdermal product development. Cetero's combination of
topical pharmacokinetics experience ensures that our clients benefit from rapid, efficient and early product optimization," said Dr. Thomas Franz, M.D., Executive Medical Director of Cetero Research.
With this service expansion, Cetero can now conduct Clinical Dermatology and TDDS multisite studies for adhesion, irritation and sensitization (A/I/S) trials across its facilities in Miami, FL; St. Louis, MO; and Toronto, Ontario, in addition to its Fargo, ND, facility. Recent Food and Drug Administration (FDA) guidances for transdermal delivery systems recommend that at least two climatically different sites should be used for assessing patch adhesion performance, and irritation and sensitization potential. Cetero has harmonized the personnel training and specific study processes across the four clinical sites, and has 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. In addition, Cetero can assist sponsors with these new regulatory recommendations, including compliance with the FDA guidance.
This multisite, one-CRO advantage also extends to special population needs, such as postmenopausal females. By utilizing multiple clinical sites when needed, Cetero can ensure full study enrollment.
In addition, the Pre-Clinical Dermatology Research Laboratory has expanded its analytical capability with the addition of two MicroMass® LC/MS/MS systems to complement its current four LC/MS and four LC/UV and GC/MS systems. The LC/MS/MS systems provide the additional level of analytical sensitivity and selectivity needed to evaluate the
dermal absorption of the most challenging compounds currently in development or production. This new equipment will allow the Pre-Clinical Dermatology Research Laboratory to expand its ability to conduct testing of
percutaneous absorption and semisolid release to GLP standards, including analytical method development and validation.