Dermal and Transdermal Research Services
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 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 dermal safety (irritation and sensitization), topical pharmacokinetics, bioavailability studies, and bioequivalence (including the vasoconstriction assay for topical corticosteroids), as well as marketing claim substantiation and medical devices has earned QPS recognition as a leading expert in the field.
QPS offers topical and transdermal 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 FIM, SAD and MAD, 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
- FIM, 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.
IN VITRO EXPERTISE
Statistics:
- 600 Studies Completed
- 100,000 Samples Analyzed
- 30,000 Franz Diffusion Cells Conducted
- 200 Franz Diffusion Cell Capacity
- 3 LC/UV Systems, 5 LC/MS systems
- 42 years of continuous operation
Bioavailability Studies for Semi-Solid and Transdermal Systems
- Percutaneous permeation pharmacokinetics characterization.
- Mass balance study designs (skin layer and residual dose assessments)
Bioequivalence for Semi-Solids
- In Vitro Permeation and Rate of Release Testing per FDA draft guidances (e.g. Acyclovir Cream).
- Preliminary screening assessments of generic test formulations and transdermal systems to reference formulations.
Systemic Safety for Rx and OTC products
- Cross species bridging, exposure assessments and formulation comparisons.
- Study designs to assess toxic exposure to noxious chemicals.
IVRT for Semi-Solids
- In Vitro release testing per SUPAC-SS and USP <1724> guidances for post-approval manufacturing and supplier changes.
Unique Study Designs
- Device delivery (e.g. microneedles, iontophoresis, etc.), heat exposure to transdermal patches, body regional variation, differentiated skin layer designs, etc.
QPS Scientists are Franz Diffusion Cell Experts
The Franz Diffusion Cell is the industry standard for in vitro percutaneous absorption kinetics of topical and transdermal products using ex vivo human skin. This model and associated methodologies support drug development in the preclinical, clinical, and post-approval phases, including the in vitro rate-of-release test (IVRT).
Leadership
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.
