Pharmacokinetics-Bridging Between Autoinjectors and Prefilled Syringes for Subcutaneous Injection: Case Examples Revealing a Knowledge Gap

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 ass...

Full description

Saved in:
Bibliographic Details
Published inClinical pharmacology and therapeutics
Main Authors Li, Zhe, Du, Xiulian, Huang, Shiew Mei, Wang, Yow-Ming C
Format Journal Article
LanguageEnglish
Published United States 01.03.2024
Online AccessGet more information

Cover

More Information
Summary: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.
ISSN:1532-6535
DOI:10.1002/cpt.3145