Tazarotene is a novel synthetic retinoid prodrug, with tazarotenic acid being an active metabolite, that can be used for treating psoriasis and acne.A generic product equivalent to Tazorac Cream, 0.05% has been developed and thoroughly characterized for qualitative (Q1), quantitative (Q2) and physiochemical and structural (Q3) equivalence. In lieu of conducting a clinical endpoint study, a PBPK model was developed. The goal was to assess bioequivalence at the site of application and systemic compartments, overcoming the limitations associated with clinical endpoint studies.
Simcyp® Simulator multi-phase and multi-layer (MPML) mechanistic dermal absorption (MechDermA) model was used for this investigation.
Bioequivalence of generic tazarotene cream was demonstrated through extensive Q3 characterization coupled with IVPT and systemic absorption/distribution profiles using a validated PBPK model, supporting the FDA approval of a generic product.
