Therapeutic Drug Monitoring
Monoclonal antibody drugs – and its biosimilars or generics – are used for various treatments and immunotherapies. The adjustment of individual doses or combination therapies is an integral element of successfully administering biotherapies. The main focus for therapeutic drug monitoring in clinical settings is on drugs with a narrow therapeutic range – drugs that can be easily under-dosed or overdosed.
Checking the drug level as well as the level of antibodies against the drug in a patients sample ensure optimised treatment plans – whether reactive or proactive.
Pro-active monitoring helps predict clinical responses in the patient before beginning their treatment, as well as maintain levels in patients undergoing treatment already. It is also used to guide therapeutic de-escalation when the treatment approaches completion. Reactive monitoring, on the other hand, helps guide the therapy after a non-response or treatment failure. For both these uses, Krishgen has a wide range of Therapeutic Drug Monitoring ELISA that are CE IVD marked.
Whether it’s monoclonal antibody drugs, biosimilars or generics for cancer immunotherapy (Trastuzumab ELISA, Bevacizumab ELISA, Alemtuzumab ELISA etc), for auto-immune diseases like Chron’s disease, multiple sclerosis, or rheumatoid arthritis (Infliximab ELISA), or even for ailments like osteoporosis or psoriasis (Ustekinumab ELISA), we have the right Therapeutic Drug Monitoring ELISA and Anti-Drug Antibody ELISA for you.
About Pharmacokinetic TDM:
Traditionally, TDM involves measuring drug concentrations in various biological fluids and interpreting these concentrations in terms of relevant clinical parameters. Clinical pharmacists and pharmacologists use pharmacokinetic principles to assess these interpretations.
Pharmacokinetics (PK) is the study of how a drug is absorbed, distributed, metabolized, and excreted over time. PK assay bioanalytical testing methods are used to determine concentration time profiles of the drug and metabolites in biological sample fluids, providing information necessary for PK analysis. PK assays are a vital component of the drug monitoring regimen process, and the data derived is used to help adjust and modify dosage in patients.
About Anti-Drug Antibody TDM:
Immunogenicity testing measures any adverse immune response generated by a biologic such as reduced efficacy or auto-immune, allergic, and anaphylactic reactions in the body. Anti-drug antibodies (ADA) bind to the drug and can lead to a decrease in drug availability in the metabolism as well as potentially even cause an allergic reaction. During clinical monitoring, quantitatively estimating the anti-drug antibody levels in patient samples helps physicians evaluate the safety of the drug for that patient, as well as determine what combination of drugs or immune suppression may be required for a successful treatment.
A suitably developed ADA assay reliably measures and validates immunogenic responses in a variety of biological matrices.