Dermal & Transdermal Research Services

QPS draws on the considerable expertise of Paul Lehman in the field of topical and transdermal pharmacokinetics and safety testing to provide our clients with a wide range of specialized research services for the pharmaceutical and toxicology industries.

Paul Lehman is well known throughout the clinical research industry, with over 33 years of experience in topical and transdermal pharmacokinetics and bioequivalence testing. He has been a Principal Investigator, Sub-Investigator, Principal Scientist or Study Director for more than 600 clinical and in vitro preclinical studies for the pharmaceutical, toxicology, skin care, and veterinary industries. His bibliography currently includes 44 published manuscripts, 5 book chapters, and over 125 poster and lecture presentations.

Paul has been an integral partner with Dr. Thomas Franz (innovator of the Franz Diffusion Cell) since 1980, developing and validating in vitro and in vivo models for topical formulations. 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 assay (IVRT) based on the FDA SUPAC-SS Guidance.

Paul’s vast experience in topical product development, lends to his active role in understanding and shaping global regulatory requirements, including EMA, FDA, and OECD.  His technical expertise in dermal safety (irritation and sensitization), topical pharmacokinetics, bioavailability and bioequivalence, and the vasoconstriction assay for topical corticosteroids, as well as marketing claim substantiation and medical devices, has earned him recognition as an expert in the field.

QPS offers dermal and transdermal research services for the development of a wide array of topical formulations including semi-solids (lotions, gels, emollients, creams, and ointments); transdermal delivery systems (patches and semi-solids); cutaneous and intradermal injectionswound dressings; and innovative delivery systems (micro-needles and iontophoresis). Our dermal and transdermal research services include:

  • Bioavailability
    • Systemic Delivery (FIM, SAD, MAD)
    • Systemic Safety and Risk Assessment
  • Bioequivalence
    • SPK for Transdermal Generics
    • Cutaneous Safety (Irritation and Sensitization)
    • Adhesion for Patch Systems
    • Clinical Endpoint BE for Dermal Products
    • Vasoconstriction for Topical Corticosteroids
  • Safety
    • Primary Irritation
    • Cumulative Irritation
    • Sensitization Assessment (HRIPT)
    • QTc
    • Chronic Exposure studies
  • Efficacy
    • First in Human
    • Phase II – Phase IV
  • Unique Study Designs
    • Topical Drying Time
    • Person-to-Person Transfer
    • Surface Deposition
    • Hand Wash and Shower Efficiency
top
20 years in pharma R&D navigation