Dermatology and Transdermal Delivery
From In Vitro to In Vivo, Experience Means Success in Studying Topical Products and Transdermal Delivery Systems
Cetero Research offers comprehensive in vitro and in vivo bioavailability, bioequivalence and safety testing services, from preclinical formulation assessments to early phase human studies, for both topical products and transdermal delivery systems. Our extensive experience spans the successive stages of product development, pharmacokinetic, safety, and claims testing, for the skin care, chemical, consumer product, and pharmaceutical industries.
In addition, we have conclusively demonstrated that in vitro results correlate with, and accurately predict, in vivo results, for well-conceived studies conducted under matched in vitro/in vivo conditions. Our highly experienced staff has worked in the academic, regulatory and pharmaceutical arenas, giving us a comprehensive appreciation of your needs as we help you progress smoothly from the earliest in vitro studies straight through to proof-of-concept.
The Franz diffusion cell and the finite dose model, which were invented by Dr. Thomas Franz, our Executive Medical Director, have become the industry standard for evaluating the performance of topical and transdermal dosage forms.
Cetero Research offers an extensive menu of in vitro studies that help you:
- Characterize skin absorption kinetics for novel drugs and/or topical and transdermal products
- Develop and select the optimal formulation
- Assess the effect of penetration enhancers/modifiers on percutaneous absorption
- Develop and validate novel analytical and sample processing methods for optimized sensitivity and selectivity
- Develop, validate, and conduct in vitro release test (IVRT) assays for FDA SUPAC-SS submissions
- Provide compliance for GLP studies, ICH Analytical Method Validations, and eCTD compatible Module 4 Final Reports
- We rapidly recruit compliant study participants, to ensure on-time study start-up
- Our highly trained team focuses exclusively on clinical dermatology and transdermal delivery system studies
- We perform Phase I pharmacokinetic studies for topical formulations and transdermal delivery systems
- We perform Vasoconstriction Potency and Bioequivalence studies for topical corticosteroids
- We perform Bioequivalence Irritation, Sensitization and DPK studies for both dermatologic formulations and transdermals
- We perform Adhesion Performance assessment studies for transdermal delivery patch products
- Our multi-site cross-trained Cetero clinics offer different climatic conditions for bioequivalence studies needing irritation, sensitization and adhesion assessments
Just tell us what your needs are and discover how well we can accommodate them.
Please visit our Scientific Exchange for articles, presentations and insights into dermatology and transdermal delivery system research.
