Dermal and Transdermal
Reputation for Excellence in Dermal Product Advancement
QPS has considerable expertise in the field of topical and transdermal pharmacokinetics, safety, and efficacy testing. We provide our clients a range of specialized clinical research services for the pharmaceutical, cosmetic and toxicology industries.
Our experience in dermal product advancement provides an active role in understanding and shaping global regulatory requirements. Our technical expertise in skin-related clinical studies, including dermal safety (irritation and sensitization), topical pharmacokinetics, bioavailability studies, and bioequivalence (including the vasoconstriction assay for topical corticosteroids), as well as marketing claim substantiation, has earned QPS recognition as a leading expert in the field.
QPS offers topical and transdermal clinical research services for product development, including semi-solids (lotions, gels, emollients, creams, foams, and ointments); transdermal delivery systems (patches and semi-solids); cutaneous and intradermal injections; wound dressings; and innovative delivery systems (micro-needles and iontophoresis).
Transdermal Pharmacokinetics CLINICAL EXPERTISE
More than 500 Studies Completed
Bioavailability Studies for Semi-Solids and Transdermal Delivery Systems
- Local and systemic delivery including First in Human (FIH), Single Ascending Dose (SAD), Multiple Ascending Dose (MAD), Proof of Concept (POC), and novel delivery systems.
Bioequivalence for Semi-Solids
- Vasoconstriction, cumulative irritation, HRIPT, and clinical-end-point studies.
Bioequivalence for Transdermal Delivery Systems
- Pharmacokinetics, irritation, sensitization, adhesion and heat/environmental exposure studies.
Safety for Rx and OTC products
- Pharmacokinetics, cumulative irritation, sensitization (HRIPT), local tolerability, and chronic exposure assessments.
Efficacy to support NDA, ANDA, and 505b2 submissions
- First in Human (FIH) and Phase II – IV clinical end point studies.
Unique Study Designs
- Trans-epidermal water loss (TEWL), drying time, person-to-person transfer, surface deposition, hand washing and shower efficiency, and tape stripping (DPK).
- Pain: local and delayed onset muscle soreness (DOMS), UV sunburn and capsaicin models.
- Device delivery (e.g. microneedles, iontophoresis, etc.), heat exposure to transdermal patches, body regional variation, differentiated skin layer designs, etc.
Our Leading Dermal and Transdermal Research Scientist
Paul Lehman, M.Sc.
The dermal and transdermal research services are led by Paul Lehman, MSc. Lehman has over 41 years of topical and transdermal pharmacokinetics and bioequivalence testing experience in 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 Lehman 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.