The FDA’s Guidance for Industry on Bioanalytical Method Validation, and us.
At the recent WRIB meeting, my friends and colleagues in the bioanalytical community discussed the past year, and our place in the biomedical industry. The topic in the spotlight was that the FDA’s “Bioanalytical Method Validation Guidance for Industry” was finalized and released to the biopharmaceutics world. After hearing and discussing the latest news, I took notice of my own place in the BioA space, and where I apply these methods. As a BioA scientist, it’s always a good notion when your own scientific practices are within the suggested guidelines set out by an organization such as the FDA.
At Lovelace Biomedical, we are up to date on all regulatory guidance, and are ready to take on your bioanalytical small molecule projects within a few weeks of contract.
Also noteworthy news – I learned that the Global CRO Council along with the International Congress on Harmonization (ICH) have released the draft guidance on bioanalytical method validation and sample analysis, so called “M-10.” At this WRIB meeting we were able to talk about the differences and similarities of this new guidance as compared to FDA, EMA, etc., and these guidance documents. I left the meeting with the feeling and enthusiasm knowing that it is an exciting time to be part of the bioanalytical community as we harmonize the requirements of excellent bioanalytical science across the world.