Friday, May 17, 2019

The strange path of Mylotarg

Pharmacokinetic/ Pharmacodynamic Modeling To Support The Re‐Approval Of Gemtuzumab Ozogamicin

This is a really cool use of in silico testing to facilitate the package for regulatory approval.  They have used the data set that existed, and then plugged it into existing models and were able to tease out the fact that there was a real therapeutic benefit at the correct dose.
Clearly this is not sufficient in itself to reapprove Mylotarg, but it was part of the package.  Pretty interesting stuff.

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