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Pharmacokinetics-Bridging Between Autoinjectors and Prefilled Syringes for Subcutaneous Injection: Case Examples
Zhe Li1, Xiulian Du1, 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.
Abstract:
Comparative pharmacokinetics (PK) studies have efficiently served as the bridge between autoinjectors and prefilled syringes given the underlying principles that comparable exposure could translate to comparable efficacy and safety. This article discusses approaches used to address uncertainties associated with the observation of noncomparable PK leading to the successful introduction of new autoinjector devices for monoclonal antibody and Fc-fusion protein products. Information from seven case examples suggests a knowledge gap that warrants attention in autoinjector development.
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