Design of Biosimilar Bioanalytical Programs:

PK assay considerations

Biosimilars are developed under the “totality of evidence” principle, which can be defined as the sum of data from analytical, preclinical, and clinical studies. There is no "one size fits all" approach to biosimilar product development.

There are numerous challenges with BIOSIM development and in this online presentation we are going to discuss some of those considerations with a specific focus on the bioanalytical strategies that are applicable for PK assays.

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Design of Biosimilar Bioanalytical Programs (PK assay considerations)

Janka presentation 2020


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