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Priceless Potency (Therapeutic Activity)

  • Geigert J
Springer International Publishing, (2019), 287-310
DOI: 10.1007/978-3-030-13754-0_10
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Abstract

The complexity of biopharmaceuticals can present significant challenges to establishing potency. In this chapter, the three types of functional activity assays for measuring potency of biopharmaceuticals will be examined: bioassay, surrogate assay, and assay matrix....

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Geigert, J. (2019). Priceless Potency (Therapeutic Activity). In The Challenge of CMC Regulatory Compliance for Biopharmaceuticals (pp. 287–310). Springer International Publishing. https://doi.org/10.1007/978-3-030-13754-0_10

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