BIOAVAILABILITY​/​BIOEQUIVALENCE

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.

Consult our general BA/BE Fact Sheet

  • 1600 completed BA/BE studies for drug submissions since 2010