David LI

Biopredictive performance testing combines in vitro and in silico methods to simulate in vivo drug absorption, but there is a lack of established standards for in vitro assays predicting specifically subcutaneous performance. Herein, agarose hydrogels with different compositions are used to mimic subcutaneous tissue characteristics and study the influence of varying drug formulations on diffusion and release kinetics. The methodology involves utilizing the USP apparatus IV and model drugs like insulin, providing a validated, reproducible, discriminatory, and biopredictive in vitro test method.