Rational arguments for regulatory acceptance of consistency testing: benefits of non-animal testing over in vivo release testing of vaccines.
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DOI: 10.1080/14760584.2023.2198601
Abstract: INTRODUCTION There are rational arguments to replace existing in vivo potency and safety assays for batch release testing of vaccines with more advanced non-animal techniques to measure critical quality attributes. However, introduction of in vitro… read more here.
Keywords: acceptance; vivo release; non animal; release ... See more keywords