Hepatic Impairment Studies
Our Special Population Capabilities
Renal Impairment
Studies
Hepatic Impairment
Studies
Other Special
Populations
Hepatic Impairment Studies
Essential for Market Authorization
Hepatic impairment significantly alters drug metabolism and safety. Both EMA and FDA require hepatic impairment studies before registration, as these data directly inform dose adjustment and labeling.
At Astrum, we conduct hepatic impairment trials from our 60-bed hospital-based Phase I unit in Porto, supported by an 11-hospital clinical research network. This combination ensures fast access to patients across the Child–Pugh spectrum, with rigorous safety oversight and global regulatory credibility.
Our Capabilities in Hepatic Impairment Studies
Child–Pugh Classification
Cohorts across mild (A), moderate (B), and severe (C) liver dysfunction.
Biomarker-Driven Designs
Integrated PK/PD and biomarker assessments to track hepatic impact on metabolism.
Flexible Study Designs
Dose-ranging, titration, and crossover protocols adapted to study objectives.
On-Site Hepatology Oversight
Access to hepatologists within our Porto unit and hospital partners to safeguard participants.
Regulatory Readiness
Studies designed to meet EMA, FDA, and ANVISA guidance, ensuring data acceptance worldwide.
Why Hepatic Studies Matter
Regulatory Requirement
Essential for drug registration and label approval.
Dose Adjustment
Determines safe dosing strategies for patients with liver dysfunction.
Risk Mitigation
Identifies metabolism-related safety concerns early.
Market Confidence
Strengthens the data package for both regulators and investors.
Why Astrum Porto
- Hospital-based Phase I unit with ICU and emergency facilities.
- 11-hospital network for rapid access to Child–Pugh classified patients.
- 400+ patient studies completed across therapeutic areas.
- Inspected by EMA, FDA & ANVISA – trusted by global regulators.
- Integrated development pathway: from early PK/PD → hepatic impairment → registrational submission.