Bioanalytics – Chemical
2019 PharmSci 360
Bioanalytics play an important role for the bioanalysis of clinical studies for bioequivalence, bioavailability and pharmacokinetics. Bioanalytics, based on the FDA bioanalytical method validation guidance and innovation are essential to advance the regulatory understanding of the drug evaluation for pre-clinical and clinical studies. Understanding the nature and scope of the guidance and it’s on-going regulatory evolution, that impacts the bioanalysis of clinical studies, will benefit sponsors and regulators.
The speakers participating in this program were involved in the preparation of FDA bioanalytical method guidance and are currently involved in the current revision and ongoing FDA studies that may be included in subsequent guidance revisions. This program will advance the general knowledge of bioanalysis for regulatory studies and will highlight innovation that may drive the next generations of bioanalytics for formulation assessment, bioequivalence, and surveillance.
The target audience will be industry scientists, academics in pharmaceutical science, regulators, CROs and specifically pharmaceutical scientists, conducting PK, BE and BE studies, chemists, bioanalytical chemists, and clinical pharmacologists.