Bioequivalence and Bioavailability Forum

Dear Gunasakaran & John!

❝ As per Canadian BE guidance […]

Since John mentioned the term “ANDA” in his/her post I guess we should refer to FDA’s practice – which is inconsistent. The prodrug should be targeted whenever possible. If we have a look at product-specific guidances, we find different cases, e.g.,

• Enalapril maleate: enalapril, enalaprilat supportive
  
• Fesoterodine: parent, 5-hydroxymethyl tolterodine supportive
  
• Lisdexamfetamine: parent, dextroamphetamine supportive
  
• Simvastatin: parent, β-hydroxyacid supportive
  
• Sulfasalazine: BE based on parent and 5-aminosalicylic acid; sulfapyridine supportive
  
• Tenofovir disoproxil fumarate: tenofovir only
  
• …

Supportive data are: Individual and mean concentrations, individual and mean PK metrics, geometric means and ratios of means for AUC and C_max.