Therapeutic Drug Monitoring / TDM

Therapeutic Drug Monitoring is a useful tool to individualize treatments in special populations (pediatric, gerontology, pregnancy, co-infections, highly variable drugs, renal or hepatic dysfunctions, treatment failure, treatments with scarce security and efficacy data, etc.)

When it is applied to the standard care, it helps to improve drug management, showing a linear relationship between drug plasma concentrations and clinical response. The interest in antiretroviral TDM in special groups of patients has increased in Argentina in the last years. In many cases, a strong correlation between plasma concentrations and efficacy or toxicity has been observed.

Antiretrovirals are excellent candidates for TDM, given that the pharmacokinetics of these drugs (especially for Protease Inhibitors) shows a large intra-and inter patient variability, suggesting a key role of TDM to optimize antiretroviral therapy and adjust the individual dosing regimen.

Biodevelop has effective agreements with the Pediatric Garrahan Hospital, Huesped Foundation and the Foundation of Infectologic Studies (FUNCEI) which imply the coordination and logistics for receiving HIV+ patients´ samples under HAART with toxicity events or treatment failures as indicated by the physician.

At Biodevelop, we developed and validated analytica methods for the simultaneous detection of antiretroviral drug groups (NRTI´s and NNRTI´s+ PI´s) with excellent sensitivity and quantification limits, which enables us to analyze-with a very small volume of plasma- three or four drugs of the antiretroviral therapy in just one analytical run.

Up to date, we validated the following methods grouping the antiretrovirals

NRTI´s: zidovudine, lamivudine, stavudine, didanosine, saquinavir, abacavir

NNRTI´s: nevirapine and efavirenz

PI´S: indinavir, nelfinavir, amprenavir, ritonavir, lopinavir

Biodevelop is a member of the International Association of Therapeutic Drug Monitoring & Clinical Toxicology (IATDMCT)