I often receive comments and queries regarding one of my publications on the subject of IVIVC and determining C-t profiles. The method for establishing C-t (blood conc.-time) profiles described in the publication [Link] appears to be quite popular and acceptable. However, readers are missing a critical aspect of the publication, i.e., the use of the crescent-shaped spindle for obtaining the dissolution data used for calculating the C-t profiles.

For successful C-t profiles development, it is critical that the in vitro dissolution test method employed must be capable of producing in vivo relevant or bio-relevant dissolution results. Unfortunately, as paddle and basket apparatuses cannot provide bio-relevant results, the methodology described in my publication may be of limited use or help for the data generated with paddle and basket apparatuses.

Therefore, please make sure that when you determine the C-t profiles, you are using a bio-relevant dissolution tester, and the associated experimental conditions, to generate in vitro dissolution results.

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