Bioanalysis in compliance to GCP/GCLP

The bioanalysis of PK samples in clinical trials needs to be performed using validated bioanalytical methods with adherence to the current ICH M10, EMA andFDA guidelines for the analysis of study samples from clinical trials.

Lablytica supports the bioanalytical phase of clinical trials with an experienced team of Analytical Chemists, Responsible Scientists as well as a Quality Assurance group. These analytical phases are performed in accordance with Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP) standards.

We have extensive experience in developing, setting-up and validating bioanalytical methods for human plasma and urine PK samples. We can transfer an existing, validated method, or we can develop an in-house method for your analyte from the start.

We are aware that there are unique challenges in every clinical trial and set up our analytical projects at Lablytica accordingly:

Phase I SAD/MAD dose escalation trials

In a Phase I Single Ascending Dose/Multiple Ascending dose clinical trial (SAD/MAD) the challenge is to have a bioanalytical method that functions well with a short time-to-result. The available time between the last sample being drawn in a cohort and the reporting of QC checked results in time for the next safety meeting assessment can be as short as 2-3 days.

Bioequivalence Studies

In a Bioequivalence (BE) clinical trial the number of samples can be significantly higher than in other trials. The study samples are usually delivered in one shipment. The bioanalytical method in this case needs to support automation and a high sample throughput in order to have results available as quickly as possible. Since regulatory authorities to a large extent rely on the bioanalytical data for a decision, a thorough method validation and study sample analysis documentation is essential from the very beginning.

Bioequivalence Studies

Once projects have reached Phase II/III there well established bioanalytical methods are usually available. The unique challenge lies in coordinating the sample sending and reception from multiple sites in multiple countries. Sites do not always have experience in shipping PK samples and care must be given to the sample reception and organization part of the analytical workflow.