Other Special Populations
Our Special Population Capabilities
Renal Impairment
Studies
Hepatic Impairment
Studies
Other Special
Populations
Other Special Populations
Beyond Organ Impairment Studies
While renal and hepatic impairment studies are critical for registration, regulators also expect data in other at-risk populations to ensure safe use in real-world settings. At Astrum, our hospital-based Phase I unit in Porto and
11-hospital research network provide controlled access to these special cohorts.
By embedding these populations into early development, we help Sponsors de-risk later stages, anticipate label requirements, and accelerate approval.
Obese Patients
Obesity can significantly alter drug absorption, distribution, metabolism, and elimination. Astrum supports:
Cardiometabolic and Endocrine Programs
PK/PD profiling in obese patients vs. normal weight cohorts
Trials in GLP-1-treated patients, a strategic component of the diabetes and obesity clinical development pipelines
Smokers
Nicotine exposure influences hepatic enzymes and respiratory endpoints. Our network enables:
Controlled Smoker and Non-smoker Cohorts
Hormonal therapies and Contraceptive Development
Safety and PK/PD Monitoring in Female Cohorts
Women’s Health Cohorts
Astrum provides early access to women’s health populations across:
Reproductive and gynecological studies
Hormonal therapies and contraceptive development
Safety and PK/PD monitoring in female cohorts
Other Patient Cohorts
Through our research network, Astrum can rapidly mobilize:
Respiratory disease patients (COPD, asthma, etc.)
Neurology cohorts, including CSF collection and analysis
Women's Health - eliminate
Why Astrum Porto
- Hospital-based Phase I unit with ICU, labs, and emergency care
- 11-hospital network for diverse patient access
- 400+ patient studies completed across indications
- EMA, FDA & ANVISA inspected – ensuring data credibility worldwide
- Seamless pathway: healthy volunteers → special populations → proof-of-concept trials