USFDA bioanalytical laboratories at Office of Testing & Research are actively engaged in participation, implementation and support of the 2018 FDA BMV Guidance through laboratory collaborations with other FDA offices (OGD, ORA & OSIS) to help better understand and advance the regulatory science of BMV. The landscape of projects includes pre-clinical and clinical studies to support the BMV guidance, and other more recent projects to investigate the analyte-matrix stability, in vitro BE studies and the impact of internal standard on quantitation. This presentation will highlight a number of regulatory science case studies including translating the laboratory study data recommendations for enhancing the BMV related guidances. The current bioanalytical method validation guidance further supported by Agency laboratory data can advance the regulatory science of BMV. Possible outcomes may include bioanalytical issues such as stability, specificity, and accuracy to assist with the application of BMV for pre-clinical and clinical studies.
Understand the regulatory scope of the bioanalytical method validation guidance.
Understand the role innovation and regulatory science play in bioanalytics
Understand the FDA prospective for bioanalysis and bioequivalence.