dOFM provides dermal BE data using a PK based approach

Currently, FDA approval for topical generic drugs requires a clinical endpoint study to show bioequivalence (BE). Standard blood PK studies are not useful for BE tests of topical dermal generics. dOFM allows a PK based BE approach directly in the skin.

Our offer


  • dOFM offers a PK based BE approach for BE testing directly in skin.
  • Test and reference listed drug (RLD) are compared in the same subject at the same time.
  • Strategic consulting for product specific guidance and ANDA meetings (505b2, Product development meeting)
  • All services required for an FDA submission are provided by our team and partners

Your Benefits


  • One PK study instead of an expensive clinical endpoint study
  • Less participants (< 50 healthy subjects) instead of hundreds of patients
  • Single-center instead of multi-center trial
  • Our approach has a reduced risk of failure compared to clinical endpoint studies.

We support the complete process of FDA approval for topical generics


Reference project


FDA-Project: Bioequivalence of drugs in the skin

A cost- and time-saving standardized OFM set-up is being developed to test dermatological generics in cooperation with US FDA.

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