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These assays may include pharmacokinetic (PK) assays, which provide information on the drug’s properties, and immunogenicity assays for the detection of anti-drug antibodies (ADA), which can lead to adverse events and reduced efficacy. Adapted from Harth S et al. (8) 8) under a CC BY-NC-ND 4.0. 2011 Oct 1;413(1):261–78.
The protocol and statistical analysis plan should clearly specify the plans for specimen collection, sample analysis and related clinical outcomes depending on the biomarker assaydevelopment and validation strategy. A related question: Which standard of care should be chosen for global master protocols? medical practice.
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