Analysis in compliance with 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. At Lablytica, 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.

We have extensive experience in developing, setting-up and validating bioanalytical methods for preclinical samples. We quantify both large and small molecules, ranging from traditional small molecule APIs, through peptides and antibody drugs, to oligonucleotides. We can transfer an existing, validated method, or we can develop an in-house method for your analyte from the start.

Bioanalysis of PK samples

The bioanalysis of PK samples from pre-clinical animal studies needs to be performed using validated bioanalytical methods in adherence to the current OECD GLP, as well as ICH M10, EMA and FDA guidelines. 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.

Dose Formulation Analysis

Dose formulation concentration confirmation, including CoA generation, is available at Lablytica.