During clinical trials, it is sometimes imperative to monitor drug levels in subjects in real-time, which allows medical monitors and clinical investigators to adjust dosing in order to meet the subject needs and study requirements. This is particularly critical in later phase trials where non-healthy volunteers are involved and their treatment regimen is dependent on accurate, timely reporting of their drug levels.
Additionally, clinical bioanalysis methodologies require central laboratory sample management and logistics support. After determination of the analytical requirements of a study, study specific materials are assembled and supplied including investigator site manual, visit specific sample collection materials and IATA/ADR compliant shipping materials. All bioanalytical data are included in the global study results database allowing combined reporting of safety parameters, biomarkers and PK data.
Daily therapeutic drug monitoring (TDM)
For some drugs under investigation, a variation in bioavailability has been observed. If these drugs also have a narrow therapeutic index, there is a great need for regularly measuring the serum or plasma drug concentrations to ensure drug effectiveness and subject safety. For instance, transplant recipients undergoing immunosuppressive therapy need to be monitored closely.
Eurofins Central Laboratory has extensive experience providing high quality, real-time data for these purposes, and has dedicated therapeutic drug monitoring (TDM) staff in its central laboratory operations in the United States, Europe and Sinapore. The combined expertise of the staff, as well as the physical proximity of the laboratories to clinical sites, allows for quality reporting of TDM results with incredible efficient turnaround.
At Eurofins, we are able to offer quantitative measurement of small molecule drug compounds and their metabolites from early development to clinical PK studies.
We go beyond analysis, routinely going the extra mile that customers wouldn't expect from a contract service organization. Challenge us with your most demanding compound and discover that we deliver excellent de novo method development, method transfer validations, and validation of bioanalytical assays to detect small molecule drug compounds as well as their metabolites.
Our DMPK portfolio extends to bioequivalence studies and drug-drug interaction studies, both in pre-clinical in vitro analyses and in clinical trials. Bioanalytical methods are developed according to the FDA Guidance on Bioanalytical Method validation and the laboratories perform under the regulations of FDA and/or OECD Principles of Good Clinical Practices.
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