Locally applied drugs [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2015-03-02 13:48 (4134 d 01:46 ago) – Posting: # 14526
Views: 6,544

Hi Melkor,

❝ I guess that a therapeutic equivalence study is then unavoidable.


In some cases you can get acceptance to do a comparative PK-study even if the substance isn't really supposed to be in the blood. It is technically quite challenging.
You better fire up the API6000 or higher...:-D

Pass or fail!
ElMaestro

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