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In cell-basedassays, pegozafermin had a similar receptor engagement profile as native FGF21, with approximately 8-fold higher potency at FGF receptor 1 (FGFR1). Pharmacokinetic half-lives ranged from 55 to 100 hours over the clinically relevant dose range, consistent with the expected half-life extension by glycoPEGylation.
As the complexity of these therapeutics increases, so must the sophistication of the bioanalytical assays designed to either quantify them or measure their impact on the patient. This includes careful consideration of pharmacokinetic and pharmacodynamic endpoints , as well as regulatory and bioanalytical requirements.
For example, we might examine the structure-activity relationship in a cell-basedassay for consistency with the structure-activity relationship that we’ve observed in the enzyme inhibition assay. We have to make assumptions in these situations and we also need to check that these assumptions are reasonable.
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