Why is Liver Injury (DILI) the Most Frequent Reason for a Drug Being Pulled from the Market
Duration: 90 Minutes
Ferreting out which Investigational Medicinal Products (IMP) might cause significant liver injury is not an easy process partly because there is confusion about how to test for liver injury and part because these AEs are rare (in the 1:10,000+ area) or "idiosyncratic" in type so are not picked up in the usual drug development process testing. We all know that AE’s are one of the key ways the Clinical Investigator has of monitoring the safety of subjects or patients in her/his charge but some are very rare so the Investigators must be ‘heads-up’. Add to this, the large number of "non-drug liver injuries, which easily confound the issue. To be forewarned is forearmed.
Determining the relationship between the study drug and an AE requires a practiced power of observation & great care (good medical judgment). Determining if an IMP is subject to liver injury separates the best PI’s from the rest.
The recent media publicity of the FDA warnings about the OTC drug acetaminophen, which is the most common drug cause for liver transplants has brought into focus the effects of drugs on the liver.
Why Should you Attend:
Whereas Drug Induced Liver Injury (DILI) is usually a rare event that is not found in the usually approval process, there are clues that all investigators and study staff must know. These will be reviewed in this Webinar.
Objectives of the Presentation:
Who can Benefit:
- When is an abnormal lab value an AE?
- What are Liver Function Tests?
- Drug effects on the liver in perspective
- Where does acetaminophen (Tylenol) toxicity fit in this process?
- What are the risk and host factors for Drug Induced Liver Injury?
- How and when do we detect "rare" events?
- What are the types of the liver’s response to drugs?
- How do ‘non-drug liver injuries fit in the concept of DILI
- The Pharmaceutical and Biological Industry who sponsor pre-approval clinical research and who are responsible for the outcome of the studies
- Principal Investigators and Sub investigators
- Clinical Research Scientists (PKs, Biostatisticians, ...)
- Research Managers
- Safety Nurses
- Clinical Research Associates (CRAs) and Coordinators (CRCs)
- Recruiting Staff
- QA / QC Auditors and Staff
- Study Monitors
- Clinical Research Data Managers.