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Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis

Camargo

One common characteristic for most if not all biologics is the triggering of an immune response or anti-drug antibodies. On the contrary, due to the complexity involved in comparing the structures of biologics, selecting the correct sampling times to prove bioequivalence for both PK and biomarkers is of primary importance.

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Clinical Catch-Up: December 21-25 | BioSpace

The Pharma Data

It is a selective modulator of neuropilin-2 that downregulates the innate and adaptive immune response in inflammatory diseases. Acer Therapeutics announced full enrollment of trial evaluating the bioequivalence of ACER-001 compared to Buphenyl (sodium phenylbutyrate) for urea cycle disorders.

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