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Bioavailability (BA) is a measurement of the rate and extent of a therapeutically active medicine that reaches the systemic circulation. BA studies typically calculate BA by comparing the blood concentration curves of compounds injected intravenously with those of oral or other routes of administration. Bioequivalence (BE) is defined as the relationship between two preparations of the same drug in the same dosage form with similar bioavailability. BE research assays are most commonly discussed in relation to generic drugs and brand name drugs. If two compounds are considered to be bioequivalent, there is no clinically significant difference in their bioavailability.
Bioavailability and bioequivalence studies are alternative markers of clinical efficacy and safety data because it is usually impractical to repeat clinical studies of generic products. For generic drugs, the study of BA/BE is necessary. In addition, once a candidate compound enters the clinical stage, researchers need to develop appropriate dosage forms with optimal bioavailability. They need BA/BE data to assess the efficacy of different dosage forms, which is critical to the quality of new drug products.
Creative Bioarray has validated a variety of methods of pharmaceutical compounds that can support your BA/BE study. Our bioanalytical laboratory is fully compliant with the GLP principles and uses the latest gas chromatography (GC), high performance liquid chromatography (HPLC), and HPLC mass spectrometry (MS) technologies for highly selective and sensitive analysis of drugs, metabolites, and endogenous compounds in biological fluids.
Our team has impeccable quality and reputable data, and we can support comprehensive research from the beginning of the study design and protocol to the release of the final clinical study report. As with all of our In Vivo services, we ensure to keep contact during studies and will contact you directly with any questions or concerns. If you have any special needs or questions regarding our services, please feel free to contact us at firstname.lastname@example.org or 1-631-626-9181 to get support from our experienced experts. We look forward to working with you in the future.
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