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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
Priv.-Doz. DI Dr. Frank Sinner
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