QPS North Dakota

Core Competencies

• In Vitro Bioavailability for Semi-Solid and Transdermal Systems:
  • Skin layer and pharmacokinetic permeation characterization.
• In Vitro Bioequivalence for Semi-Solids and Transdermal Delivery Systems:
  • Per FDA draft guidances (e.g. Acyclovir Cream) in lieu of clinical-end-point studies
  • Preliminary assessments of generic formulations and transdermal systems.
• In Vitro Systemic Safety for Rx and OTC products:
  • Cross species bridging, exposure assessments and formulation comparisons.
• In Vitro Rate of Release for Semi-Solids:
  • In Vitro release testing per SUPAC-SS for post-approval manufacturing and supplier changes, and USP and FDA BE guidances.
• Analytical method development, implementation and validation of quantitative HPLC/UV and LC/MS/MS assays for small molecules.
• Unique Study Designs:
  • Device delivery (e.g. microneedles, iontophoresis, etc.)
  • Heat exposure to transdermal patches
  • Body regional permeation variation
  • Differentiated skin layer designs, etc.

Facility

• The Dermal & Transdermal Research Laboratory is located in the PRACS Building in Fargo, ND
• Our dedicated 5,000 sq-ft, laboratory is a fully integrated operation, from skin penetration studies, on as many as 200 parallel Franz diffusion cells, full analytical services, to comprehensive QC/QA.
• LC-MS/MS and HPLC/UV capabilities for sample analysis.
• Onsite secured archiving.

Achievements

• Perfect US FDA inspection record (no 483s or observations).
• No employee has been debarred or in proceedings for debarment by the US FDA.
• Awarded US FDA contract (2016) for evaluating skin permeation and release rates to physicochemical vehicle properties.

Experience

• Averaging over 2,000 Diffusion chambers dosed per year.
• Averaging over 21,000 samples assayed per year.
• Same location since 2005 in a specially designed facility for permeation studies.
• Led by Paul Lehman, V.P.
  • Paul has over 41 years of experience in topical and transdermal pharmacokinetics and bioequivalence testing for the pharmaceutical, toxicology, skin care, and veterinary industries.
  • His bibliography currently includes 51 published manuscripts, 6 book chapters, and over 130 poster and lecture presentations.
  • Paul has been an integral partner with Dr. Thomas Franz (innovator of the Franz Diffusion Cell) since 1979, developing and validating in vitro and in vivo permeation models for topical and transdermal formulations.