The Development And Validation Of Specific Ligand Binding Methods For The Determination Of Parathyroid Hormone (1-34) And (1-84) In Human Plasma For Pharmacokinetic Sample Analysis

Parathyroid hormone (PTH) is an 84 amino acid polypeptide produced in the parathyroid gland and plays a major role in regulating serum calcium concentrations. PTH (1-34) is a polypeptide consisting of the 34 N-terminal amino acids of the intact PTH (1-84) which shows similar effects on serum calcium regulation.

Methods for determining PTH (1-84) in human plasma need to account for endogenous concentrations of the intact peptide when preparing controls and calibrators in plasma. Methods for determining PTH (1-34) in human plasma also need to account for antibody cross-reactivity with endogenous PTH (1-84).

Commercially available PTH (1-84) kits and PTH (1-34) kits were adapted and validated to meet FDA guidelines for validation of bioanalytical methods.

The validated methods allow for rapid, selective, accurate and reproducible quantitation of PTH (1-84) and PTH (1-34) in human plasma samples for pharmacokinetic evaluation.