Developing anti-drug antibody (ADA) assays for therapeutic peptides can be complex, particularly when the molecule is small, endogenous-like, and when no positive control exists. This article describes the stepwise development of a screening and confirmatory ADA assay for a 47-amino acid peptide targeting a receptor involved in inflammation in…

The Role of Pharmacokinetics (PK) in Drug R&D Pharmacokinetics (PK) is defined as the study of the fate of a new therapeutic entity (NTE) after it is administered into the body of animals or humans. It involves understanding how the drug is absorbed, distributed, metabolized, and eliminated (ADME). Essentially, PK…