Director US Food and Drug Administration Silver Spring, Maryland
Model-informed drug development is a key PDUFA VI initiative that has been applied to improve the efficiency of drug development across many disease areas. The unique challenge of COVID-19 has also triggered a wave of model-based analyses to support various decisions related to potential treatments for COVID-19. This talk will focus on the in-vitro-in-vivo correlation for hydroxychloroquine (HCQ) to evaluate whether the in vivo exposure under the approved dosing regimens for HCQ is sufficient to have any potential anti-viral effect. The role of this analysis in FDA's decision to revoke the Emergency Use Authorization (EUA) for HCQ will also be discussed.
Understand how in vitro experiement is conducted to evaluate the antiviral potential of drugs agains SARS-COV-2
Understand the reason for the high tissue concentration for hydroxychloroquine
Understand the correct in-vitro-in-vivo correlation for hydroxychloroquine
Understand the difference among blood, serum and plasma concentrations of hydroxychloroquine
Understand the importance of randomized clinical trials to determine the efficacy of hydroxychloroquine