Tag: ba be studies

Clinical research is an integral component of scientific inquiry. While individuals may receive quality patient care or treatment through taking part in studies, its primary goal should be generating useful knowledge that benefits everyone involved. Recently, the Food and Drug Administration issued new guidance for sponsors regarding bioavailability (BA) and bioequivalence (BE) studies they must…

Bioavailability (BA) and bioequivalence (BE) studies are an integral component of drug development. They involve comparing two pharmaceutical dosage forms (test and reference) in a randomized clinical trial involving healthy volunteers to assess bioavailability (BA) or bioequivalence (BE). BE trials typically focus on adult populations; however, their findings can also be applied directly to pediatric…