Recently, the American Association of Pharmaceutical Scientists (AAPS) released a post on their blog authored by Binodh DeSilva, Executive Director of Immunochemistry and Biomarker Development and Mark E. Arnold, Ph.D., Executive Director of the Bioanalytical Sciences and Selective Integration Department at Bristol Myer Squibb on the FDA and industry discussing crucial draft bioanalytical method validation guidance. Here is an excerpt from the post:
In September, the draft revision to the U.S. Food and Drug Administration (FDA) Guidance on Bioanalytical Method Validation was released. It has the potential to significantly alter the manner in which pharmacokinetic (PK) and biomarker measurements are conducted. Thus, the bioanalytical community in pharmaceutical and biotechnology companies, contract research organizations (CROs) and quality assurance groups are studying and commenting on the revision.
Read the rest of the post on the AAPS Blog here.