Pharmacologist US FDA Silver Spring, Maryland, United States
The nonclinical toxicology studies to support safe use of drug products in humans must take into account the clinical route of administration. This talk will present a case study to address systemic and local safety for the intra-articular (IA) route of administration and how to derive safety margins to support human dosing based on local toxicity findings. The audience will be asked to determine if the nonclinical toxicology studies are designed appropriately and if there is adequate coverage of the clinical paradigm. Learning objectives: 1) understand points to consider when developing the nonclinical strategy for a drug administered by the IA route (i.e., NME, novel excipients, drug concentration, volume administered, clinical dosing regimen, etc), 2) understand how to establish local exposure margins for drugs administered by the IA route, and 3) understand that each new drug should be approached on a case-by-case basis and to consult the review division early during development.
