Rationale | Requirement |
Pharmacokinetic interindividual variability | Valid assay for drug concentration measurement and anti-drug antibody detection |
Dose–concentration relationship | Algorithm based on clinical and biological assessment |
Risk of adverse events, outside the target concentration range* | Personalised dosing-schedule modelling tool, to achieve the target concentration and response |
↵*Immunogenicity with low concentrations and infection with high concentrations.