Draft Guidance on Bioanalytical Method Validation and Sample Analysis Released
The Global CRO council, along with the International Congress on Harmonization (ICH) have released the draft guidance on bioanalytical method validation and sample analysis (http://www.ich.org/products/guidelines/multidisciplinary/multidisciplinary-single/article/bioanalytical-method-validation.html). At the recent WRIB meeting, bioanalytical scientists and regulators discussed the difference and similarities of this new guidance as compared to FDA, EMA, etc. guidance documents (https://www.wrib.org/main-workshop-days.php). This is an exciting time to be part of the bioanalytical community as we harmonize the requirements of excellent bioanalytical science across the world. At Lovelace Biomedical, we are up to date on all regulatory guidance, and are ready to take on your bioanalytical small molecule projects. With Lovelace’s recent increase investments in mass specs and staff, the team is ready discuss your immediate needs. For more information, contact our business development team.