Abstract:
The aim of establishing a bio-relevance dissolution method is to predict pharmacokinetics process
in vivo via an appropriate dissolution test. In recent years, studies have shown that the dissolution profile obtained in bio-relevance dissolution medium with suitable dissolution test device can reflects the dissolution process
in vivo. Computer simulation software can offer a guide and basis for establishing a reasonable dissolution test. By using suitable bio-relevance dissolution medium, dissolution test device and computer simulation software, level A IVIVC(
in vitro-
in vivo correlation) could be established, which could replace bioequivalence studies.