Pharmacokinetic / pharmacodynamic (PK/PD) correlations for peptide and protein-based drugs are frequently convoluted by their close interaction with endogenous substances and physiological regulatory feedback mechanisms. Extensive use of pharmacokinetic and exposure/response concepts in all phases of drug development has been identified in the past as a crucial factor for the success of a scientifically driven, evidence-based, and thus accelerated drug development process. Accuracy, precision, and specificity remain paramount criteria for those interpreting assay results.
VelaLabs has extensive expertise in implementing PK assays for various clinical studies and different drug products.
Antibody formation is a frequently observed phenomenon during chronic dosing of biotechnological drugs, especially when the drugs are derived from animal proteins. The presence of antibodies can obliterate the biological activity of a peptide or protein drug. Furthermore, protein-antibody complexation may modify its pharmacokinetic profile.