Bioanalytical Assays to support Denosumab 

Somru developed the following comprehensive list of  bioanalytical assays to support Denosumab biosimilar  development 

  1. Pharmacokinetic Assay (PK) assay 
  2. ADA assay 
  • Binding ADA assay 
  • Cell-based NAb assay(s) 
  • Ligand Binding NAb Assay  
  1. Pharmacodynamic Assays 
  • sCTX 
  • TRAP-5b 
  • P1NP
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