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
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