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A Risk-Based Assessment for Determining the Pharmacokinetic Comparability Requirements of Biologic-Device Combination

Mark Klitgaard Nøhr1, Shaik Rizwan Waheed2, Rasmus Juul Kildemoes3

  • 1Regulatory Affairs, Chemistry, Manufacturing and Controls, Novo Nordisk A/S, Søborg, Denmark.

The AAPS Journal
|September 4, 2024
PubMed

Keywords:
biologic-device combination productpharmacokinetic comparabilitysubcutaneous administration

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