Bioavailability (BA) and bioequivalence (BE) studies play a most important role in the development of both novel drug products and their generic equivalents. There are many methods to assess BE, and every regulatory authority has its own regulations for conducting BA/BE studies. Universal Clinical Trials experts know to size the study properly to achieve adequate statistical power; certify that the proper overall design can sufficiently address the question at hand; standardize the environment (e.g, fed, ambulatory/fasting/supine); and strictly follow to and document Good Clinical Practices (GCP). For the smooth performance of BE studies, all such factors are reflected in advance and involved in the protocol and study plan.
Our bioanalysts employmeticulous research laboratory practices and cautious operating procedures. They are well knowledgeable about each regulatory authority’s specifications and requirements. Our bioanalysts select an suitable analyte to be measured and enroll the precise number of subjects to provide adequate power for testing the hypothesis.