2019 PharmSci 360
Using examples from a pre-clinical study, this rapid fire presentation builds upon the concept of utilizing integrated pharmacokinetic (PK) and pharmacodynamic (PD) biomarker data to inform the presence of neutralizing activity. For molecules with antagonistic mechanism of action, neutralizing anti-drug antibodies (NAb) can impact exposure levels and subsequently affect PD and efficacy. Therefore, the presence of reduction (or loss) of PK and PD upon dosing, can provide indirect evidence of an immunogenic response with neutralizing impact against the therapeutic. In addition, the case study will highlight how PK/PD data integration, in presence or absence of ADA results, provides insight into exposure levels required to maintain biological activity.