Drug-Induced Live Injury – Causes, Identification and Risks

This afternoon at the DIA Pharmacovigilance and Risk Management Strategies Conference in Washington, D.C, we are digging down into one of the cruxes of surveillance in pharmacovigilance (PV); drug-induced live injury (DILI). Vicky and I attended a panel consisting of hepatic experts sharing information on the latest drug-related DILI and the best way to detect it.

While we know much about the importance of hepatic function for drug metabolism and clearing the drug; it’s been a reality check. DILI is now more iterative to detect; there is no gold standard. In fact, ten percent of marketed drug withdrawals are due to DILI.

There are three types of Drug-Induced Live Injury:

1. Direct (meaning dose-related to the drug)
2. Indirect (effects of the drug that are unanticipated)
3. Idiosyncratic (meaning we are idiots and don’t know the cause).

How Artificial Intelligence Can Enhance the Clinical Data Review and Cleaning Process

This guide analyzes how artificial intelligence – including machine learning – can be used by pharmaceutical and medical device companies to improve the clinical data review and cleansing process.

Get the Guide

The bottom line is surveillance of the PV data throughout the life cycle of the drug to surely for DILI; it can be a deal-breaker for treatment. Know what you are looking for and find it quickly. Also, with the entry of new drug categories such as biologics; we are learning that it’s far more complex to diagnose.

Join us for a webinar

Perficient will be hosting a webinar on February 6th, 2020, where PV – Hawk will be demonstrated, including its ability to compare PV data with other sources of data such as FDA AERS.

About the Author

Kari Blaho-Owens, Ph.D., received her graduate degree in pharmacology and clinical therapeutics from LSU Medical Center in New Orleans, Louisiana, US. She was the Research Director and clinical toxicologist consultant in an inner-city Emergency Department at UT College of Medicine and has spent much of her career in the life sciences industry working for pharmaceutical and device companies, as well as CROs. She also served as the global head of PV at a major company. Kari is currently the head of PV at Perficient, where she leads a team that implements fit-for-purpose technology solutions and provides pharmacovigilance consulting. She is also a peer reviewer for the DIA.

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