1 / 9

Understanding Highly Variable Drugs (HVD) and Highly Variable Drug Products (HVDP)

Highly Variable Drugs (HVD) and Highly Variable Drug Products (HVDP) are defined by their variability in pharmacokinetics, particularly when the ANOVA-CV exceeds 30%. This high variability necessitates larger sample sizes in traditional bioequivalence (ABE) studies, even with two samples. The distinction between HVD and HVDP is critical for regulatory considerations in drug development, affecting study design and approval processes. This guide provides an overview of the implications and requirements for testing these unique drug formulations.

mliss
Télécharger la présentation

Understanding Highly Variable Drugs (HVD) and Highly Variable Drug Products (HVDP)

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

    More Related