Pharmacokinetics & Pharmacodynamics (PK/PD)
PK/PD Studies – Porto, Portugal
The Foundation of Early Development
Pharmacokinetics (PK) and pharmacodynamics (PD) are the backbone of early clinical research — defining how a drug behaves in the body and how it exerts its effect.
At Astrum, we deliver robust PK/PD data from our 60-bed hospital-based Phase I unit in Porto, helping Sponsors make confident dose, safety, and proof-of-concept decisions. Our studies are recognized by EMA, FDA, ANVISA, and other worldwide regulatory agencies — with recent submissions and inspections, including by NPRA (Malaysia), confirming global acceptance and quality standards.
Why PK/PD Matters
- Establishes how a drug is absorbed, distributed, metabolized, and excreted (PK)
- Explains the biological effect and therapeutic potential (PD)
- Supports dose selection, escalation strategies, and safety margins
- Provides essential evidence for regulatory approval and investor readiness
Our PK/PD Capabilities
First-in-Human & Dose-Escalation Studies (SAD/MAD, FIH)
Drug–Drug & Food–Drug Interaction Studies
Food Effect Evaluations
PK/PD Modeling & Simulation (NCA, IVIVC, ER analysis, WinNonlin®)
QTc & Cardiac Safety Assessments
Proof-of-Concept Trial Designs integrated with PK/PD data
Access to Special Populations
Through Astrum’s 11-hospital research network in Portugal, we provide PK/PD insights across patient groups critical for translational research:
Renal & hepatic impairment (mild → severe, including dialyzed)
Obese & GLP-1 treated
patients
Smokers & respiratory cohorts
Women’s health populations
Why Astrum for PK/PD
- Hospital-based unit with ICU, labs, and emergency backup
- 60 dedicated beds, among Europe’s largest Phase I capacities
- Regulatory credibility – inspected by EMA, FDA & ANVISA
- Proven delivery – hundreds of PK/PD studies successfully executed
- Biotech-friendly – flexible support balancing rigor, timelines, and investor goals