Altasciences has been at the forefront of bioavailability (BA) and bioequivalence (BE) testing since our founding. Our team of pharmacokineticists leverages a study design database for more than 1,200 products or combinations, many based on in-house data.
Our clinics have specially designed units for dosing of up to 72 participants in a single group. We continually validate new bioanalytical methods and have developed over 620 validated methods to date.
Our experience includes:
- Absolute bioavailability testing as part of FIH studies, or later in clinical development.
- Comparative bioavailability studies on hundreds of new formulations or routes of administration; e.g., immediate vs. extended release and oral dosing vs. inhalation.
- Bioequivalence testing (small molecules and biologics) required for change in manufacturing, Hybrid or 505(b)(2) applications, or for generic and biosimilar submissions.
- 1600 completed BA/BE studies for drug submissions since 2010
Our deep expertise and capabilities in a broad range of therapeutic areas encompasses preclinical and early clinical studies for both small molecules and biologics. We can manage your entire program, as well as provide support research services and bioanalytical expertise.
Please see Therapeutic Areas for a fuller discussion of our capabilities and expertise.