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Biodisponibilité/Bioéquivalence

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

DOMAINES THÉRAPEUTIQUES

Notre vaste expertise et nos capacités approfondies dans toute une gamme de domaines thérapeutiques visent notamment les études précliniques et cliniques pour les petites et grandes molécules. Nous pouvons gérer l’ensemble de votre programme et vous fournir des services de soutien à la recherche, et nous mettons à votre disposition notre expertise bioanalytique de grande renommée.

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Working as a flexible, attentive extension of your team, we offer all you need to move your molecule forward.