Cetero Research, the leading early-stage contract research organization (CRO), today 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, highly-advanced equipment.
"There are very unique complexities surrounding topical and transdermal product development. Cetero's four decades of combined in vitro and in vivo 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 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. 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 complete study enrollment.
"Our team understands how critical factors such as dose application and removal, skin conditions and diseases, lifestyle history and adverse event assessment (skin and systemic) will impact how the skin absorbs a compound, assuring the design of studies to control for those details," said Dr. Alan Copa, President of Clinical Operations -- Fargo for Cetero Research. "This understanding, combined with our advanced technology, allows our integrated team of dermatology experts to seamlessly leverage their knowledge into the design and performance of clinical trials."
In addition to adding functionality at its clinical facilities, 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 in vitro dermal absorption of the most challenging compounds currently in development or production. This new equipment will allow the Pre-Clinical Dermatology Research Laboratory to further expand its ability to conduct testing of in vitro percutaneous absorption and semisolid release to GLP standards, including analytical method development and validation.
"The ability to offer custom-designed studies and work as a true partner with study sponsors sets Cetero apart as the leader in dermatology and transdermal applications," added Dr. Copa. "We have collaborated extensively with the FDA, the United States Pharmacopeia and international agencies to assist in the development of guidances and acceptable study design. All studies at Cetero can be performed to FDA, International Conference on Harmonisation (ICH), European Medicines Agency (EMA) and Organisation for Economic Co-operation and Development (OECD) specifications as needed to facilitate regulatory approval."