Analysis in compliance to OECD GLP

The analytical phase of formal GLP studies needs to be performed according to the OECD Series on Principles of Good Laboratory Practice (GLP) and Compliance Monitoring. Method validation and PK study sample analysis is performed according to the ICH M10 guidelines.

Lablytica is part of the Swedish accreditation body’s (SWEDAC) OECD compliance and inspection program. The analytical project phases of pre-clinical animal studies performed at Lablytica are regularly inspected by SWEDAC.

Bioanalysis of PK samples

The bioanalysis of PK samples from pre-clinical animal studies needs to be performed using validated bioanalytical methods and an adherence to the current OECD GLP as well as ICH M10, EMA and FDA guidelines for the analysis of study samples. Lablytica supports the bioanalytical phase of pre-clinical studies with an experienced team of Analytical Chemists, Principal Investigator as well as a Quality Assurance group. These analytical phases are performed in compliance with the OECD Good Laboratory Practice (GLP) standards.