Dermal Bioequivalence Studies
Fast and efficient PK-based bioequivalence studies for topical generics
Our innovative dOFM Technology provides dermal bioequivalence (BE) data using a pharmacokinetic-based approach. Currently, FDA approval for topical generics requires a clinical endpoint study to demonstrate bioequivalence. Standard PK studies with blood samples are not suitable for BE testing of topical dermal generics. dOFM enables a PK-based BE approach directly in the skin.
Our Services
- PK-based approach for bioequivalence tests directly in the skin
- Test and reference drug are compared at the same time on the same subject
- Strategic advice for product-specific guidelines and ANDA meetings (505b2, product development meeting)
- All services required for an FDA submission are provided by our team and our partners
Your Benefits
- one PK study instead of an expensive clinical endpoint study
- fewer participants (< 50 healthy volunteers) instead of hundreds of patients in a BE study
- a single center instead of a multicenter study
- our approach has a lower risk of failure compared to clinical endpoint studies
Research groups
Downloads
Shareholdings & Funding
Das sagen unsere Kunden
More Products and Services
Unique de-risking and proof-of-mechanism studies for dermal active ingredients
Specialized methods for analyses and testing for preclincial and clinical studies (GLP and non-GLP).
Instruments and methods for the measurement of pharmacokinetics and pharmacodynamics in different tissues.
Comprehensive and compliant data management and biostatistics for clinical trials
We test drug release in a fast and reliable way using IVRT based on vertical diffusion cells and synthetic membranes.
We perform untargeted and targeted metabolomics studies to quantify metabolites to investigate metabolic processes and identify biomarkers.
The digital checklist and cross-professional process documentation for surgical procedures.
CDS-BARS module for patient-centered, cross-professional, interdisciplinary collaboration and documentation on acute geriatric wards
We offer extensive, professional support in reporting and publishing the results of your preclinical and clinical studies.
aOFM can be used to monitor local drug distribution and biomarkers in subcutaneous adipose tissue.
