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Published on: May 13, 2020
Insights into PK-Based Bridging for Products Using a Common Autoinjector Platform: A Review of 16 Autoinjectors in 14
Zhe Li1, Pei-Rung Huang1,2, Shiew Mei Huang1
1Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration (OCP/CDER/FDA), Silver Spring, Maryland, USA.
None:
An emerging proposal suggests that prior findings of pharmacokinetic comparability for one product could be applied to other therapeutic protein products that use the same autoinjector platform. We investigated 16 autoinjectors using one platform and found that (a) pharmacokinetic comparability outcomes varied and (b) these outcomes were not attributable to identified device performance parameters or product viscosity. Further investigations are necessary to support the proposed extrapolation across products sharing the same autoinjector platform.
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