Hepatology is the study of the liver, related organs and structures, and their associated diseases. In addition to the liver, hepatology also includes within its purview the gallbladder, bile ducts, and the exocrine functions of the pancreas. The liver performs upwards of 500 critical functions.1 The liver’s central role in drug metabolism is of critical importance to drug developers, not only for hepatology indications but any time a drug is introduced into the blood.
There are many types of liver disease with many potential causes. Infection with viruses, such as those that cause hepatitis A, B, or C, can cause liver damage. Liver diseases can also be triggered by autoimmune conditions, genetic mutations, alcohol abuse, or fat accumulation in the liver. There are also a number of cancers that can affect the liver and associated organs and tissues.
Liver impairment (i.e., hepatic impairment) occurs when the liver exhibits a decreased ability to perform its normal functions. Because of the role that the liver plays in drug metabolism, hepatic impairment is a key concern when determining drug dosages for patients. Individuals with hepatic impairment also comprise significant subpopulations for many indications. As such, studies in individuals with hepatic impairment are often required for a drug to gain marketing approval from the FDA or other regulatory bodies.
Nuventra’s consultants have many years of experience determining the impact of hepatic impairment on drug disposition. Often, the effects of liver dysfunction can be simulated using pharmacokinetic models, removing the need for expensive and difficult clinical trials (for more information, please see our blog post on how to avoid a hepatic impairment study). If clinical trials are required, careful planning and appropriate study design are critical to success. Nuventra’s consultants are experts in designing studies involving patients with hepatic impairment.
1. Johns Hopkins Medicine Health Library. Liver: Anatomy and Functions. https://www.hopkinsmedicine.org/healthlibrary/conditions/liver_biliary_and_pancreatic_disorders/liver_anatomy_and_functions_85,P00676
Nuventra’s Hepatology Experience
Nuventra can perform any of our wide range of services for drugs to treat Hepatology indications. Nuventra has worked on Hepatology indications from the preclinical stage through post-marketing (Phase 4). Some of our recent project experience in this area includes:
- Clinical Development Plans
- Clinical Trial Management
- Data Management
- Due Diligence
- Full Regulatory Department Support
- Population Pharmacokinetic (popPK) Modeling
- Regulatory Writing
- Type C meetings
Visit our services page to see our full range of services and to learn more about what our drug development consultants can offer your program.
Nuventra has experience with a number of Hepatology indications, including:
- Hepatic Encephalopathy
- Hepatitis C Virus (HCV) Infection
- Liver Transplant
- Nonalcoholic Steatohepatitis (NASH)