Co-Sponsored by the Drug Safety Working Group (ISoP Quantitative Systems Pharmacology SIG) and the ISoP-ACCP Clinical Pharmacometrics SIG
Drug safety concerns can critically impact the approval or availability of an efficacious drug and therefore demand efforts to mitigate the likelihood of adverse events. However, these efforts are complicated by major challenges in drug safety, including a dearth of data, narrow therapeutic windows, uncertainty in culprit molecular entity, and off-target mechanisms of toxicity.
Different quantitative approaches have been taken to improve drug safety; encouraging greater cross-disciplinary awareness may provide opportunities to more fully leverage all available quantitative tools. In that spirit, this 2-part webinar series will illustrate how pharmacometric approaches such as therapeutic drug monitoring (TDM) have been used to inform dosing at the bedside to ensure efficacious and safe doses are administered to individual patients (Speakers: Andrea Edginton, PhD and Michael Neely, MD), to link drug concentrations to safety and efficacy biomarkers for early identification of potential risk, and to guide dosing targets. These sessions will also illustrate how quantitative systems pharmacology (QSP) approaches can be used to demonstrate the plausibility – or lack thereof – of mechanistic hypotheses for adverse events, to compare potential liabilities of drugs in the same class, or to prospectively investigate margin of safety (Speakers: James Lu, PhD and Melissa Hallow, PhD).
Greater awareness of alternate approaches between the two communities holds promise for innovative collaborations for greater improvements in the area of drug safety.