Bioequivalence testing of topical generics


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

Bioequivalence of drugs in the skin

In cooperation with the US Food and Drug Administration (FDA) we have successfully established a new methodology to determine the bioequivalence of drugs in the skin.

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