Bioequivalence

Fast and efficient PK based bioequivalence testing of topical generics.

 

 

 

 

Our innovative dOFM (dermal open flow microperfusion) sampling technology 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 Services

  • 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

Our Expertise

  • 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

More information

To learn more about our innovative technology and its application, please visit our dedicated OFM website.

Contact Us

 

Learn more about OFM

Schedule a conversation with
our OFM Experts.

 

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