Population pharmacokinetics: Drugmakers seek clarity and additions to revised FDA guidance
About a dozen drugmakers and industry groups recently offered their opinions on a revised FDA draft guidance related to population pharmacokinetics (PK) analyses submitted as part of new drug applications and biologic license applications.
The comments largely seek specific tweaks to the 23-page revised draft, which was released in July, although some of the comments also seek further clarity and new additions to the guidance.
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