Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis
Camargo
DECEMBER 13, 2021
Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. Use of PK and PD similarity data can remove the need for a comparative efficacy study for a biosimilar approval and lead to a more efficient, streamlined program.
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