Justification of disintegration testing beyond current FDA criteria using in vitro and in silico models

Abstract

Drug product performance testing is an important part of quality-by-design approaches, but this process often lacks the underlying mechanistic understanding of the complex interactions between the disintegration and dissolution processes involved. Whereas a recent draft guideline by the US Food and Drug Administration (FDA) has allowed the replacement of… (More)
DOI: 10.2147/DDDT.S131213

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