Early Stage Clinical

QPS’ Dermal and Transdermal Research Services are off to a rapid start with the first Sponsored study completed at QPS Bio-Kinetic site in Springfield, MO - November, 2013

Paul Lehman joined QPS in July to direct our new Dermal and Transdermal contract research services division. In October, our Phase I site in Springfield, MO successfully completed their first Sponsored vasoconstriction study for topical corticosteroid bioequivalence under Paul’s supervision. This study encompassed a dynamic team effort with extensive training, protocol writing, study conduct, statistical analysis and, currently in progress, final report preparation.

This first study package involved a sequential study series where an initial group of subjects were used to determine the vasoconstriction dose responsiveness of the reference formulation, followed by a pivotal study to determine the bioequivalence of a test formulation to the reference. These studies follow the 1995 FDA Guidance for determining bioequivalence of topical corticosteroids.

New contracts for Dermal and Transdermal studies have already been inked and negotiations with multiple clients are underway which lead us to believe that our high-quality Phase I units, Paul Lehman’s recognition in the industry, and our specialized Dermal and Transdermal contract research services are being embraced by the industry. Exciting times are ahead for this new division within QPS!

QPS offers Phase I Dermal and Transdermal PK, BA/BE, irritation, sensitization (HRIPT), and adhesion study designs in our Springfield, MO and Miami, FL clinics, through to Phase II, and special population clinical studies which can be conducted at many of our clinic sites around the world.

For more information on QPS’ Dermal and Transdermal contract research services and capabilities, please contact:

Mariya Rzaszutak, MBA
Director, Business Development
3 Innovation Way
Newark, Delaware, USA

Phone: 970.377.0699
Mobile: 302.235.9032
Email: mariya.rzaszutak@qps.com

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