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
openflowmicroperfusion.com

More information

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

Contact Us

 

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