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Piet_Hoogkamer
Level III

Comparative Dissolution Testing

Dissolution (or in vitro release) studies mimic the diffusion of an active molecule from the gastrointestinal tract into systemic distribution. Comparison of dissolution profiles (%released vs. time) play an important role in development and in post marketed changes, justifying a biowaiver. Several metrics have been published over the last 27 years, and the debate on which one to use continues. JMP started to support these analyses, however, support for latest developments is currently lacking, which will be highlighted here.

 

Piet
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