Bioavailability & Bioequivalence (BA/BE) Studies
Bioavailability & Bioequivalence (BA/BE) Studies
– Porto, Portugal
Proving Consistency and Confidence
Bioavailability (BA) and bioequivalence (BE) studies are essential for demonstrating that medicines deliver consistent therapeutic effects. Whether supporting new formulations, generics, or 505(b)(2) submissions, Astrum provides globally recognized BA/BE data from our 60-bed hospital-based Phase I unit in Porto.
Our studies are fully compliant with EMA, FDA, and ANVISA regulations, giving Sponsors confidence in worldwide regulatory acceptance.
Why BA/BE Matters
Bioavailability (BA):
Measures the rate and extent to which an active ingredient is absorbed and becomes available at the site of action.
Bioequivalence (BE):
Confirms that a generic or reformulated product matches the performance of a reference drug.
confidence in development programs.
Our BA/BE Capabilities
Single & Multiple Dose BA/BE Studies
Generic and Biosimilar Development Programs
505(b)(2) Pathway Studies
Food Effect Evaluations
Adaptative design for precise comparative data
Population PK support to optimize interpretation
Access to Special Populations
Leveraging Astrum’s national hospital research network, we deliver BA/BE insights across targeted patient cohorts when required:
Renal & hepatic impairment
studies
Obese & metabolic patients
Women’s health populations
Why Astrum for BA/BE
- Hospital-based Phase I unit ensures safety and speed, even in complex studies
- 60 dedicated beds – capacity for large, multi-cohort BA/BE programs
- Regulatory confidence – EMA, FDA, and ANVISA inspected for the conduct of bioavailability/bioequivalence (BABE) studies
- Experience across 400+ patient and volunteer studies in Portugal
- End-to-end support – from study design to regulatory submission packages