Original Publication Date: 14 September, 2018
Publication / Source: Bioanalysis 10(18)
Authors: Kakkanaiah VN, Lang KR & Bennett PK
Pharmacokinetics (PK) defines the disposition of a drug in the body based primarily on measurements in fluids or tissues by various bioanalytical methods during the drug development. Most bioanalytical methods utilize ligand-binding or LC–MS technology, and the assays are validated and applied following the guidelines from various regulatory agencies in their countries (e.g., US FDA, EMEA or Health Canada) . These bioanalytical method guidelines focus on the PK of traditional drug compounds; small molecules and large biomolecules.
The CAR-T (chimeric antigen receptor) cell therapies, recently approved by FDA, involve administration of ‘living drugs’ capable of