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Related Experiment Videos

Antibiotic batch certification and bioequivalence.

K A DeSante, A R DiSanto, D J Chodos

    JAMA
    |June 30, 1975
    PubMed
    Summary
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    Different brands of tetracycline hydrochloride passing Food and Drug Administration batch tests showed varying serum concentrations in vivo. This highlights that in vitro antibiotic batch certification does not guarantee equal in vivo bioavailability.

    Area of Science:

    • Pharmacology
    • Drug Regulation
    • Clinical Pharmacy

    Background:

    • Antibiotics require Food and Drug Administration (FDA) batch certification for market release in the US.
    • A common assumption is that antibiotic brands passing in vitro tests exhibit equivalent in vivo bioavailability.

    Purpose of the Study:

    • To investigate the in vivo bioavailability of different brands of tetracycline hydrochloride.
    • To challenge the assumption that in vitro batch certification ensures equal in vivo performance.

    Main Methods:

    • Commercially available lots of tetracycline hydrochloride were selected.
    • All selected lots had passed FDA batch certification tests.
    • Serial serum concentrations were measured in vivo to assess bioavailability.

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    Main Results:

    • Significant variations in serum concentrations were observed among different tetracycline hydrochloride brands.
    • These differences persisted despite all lots having passed in vitro batch certification.

    Conclusions:

    • In vitro antibiotic batch certification by the FDA is not a reliable predictor of in vivo bioavailability.
    • Clinical outcomes may differ between antibiotic brands due to bioavailability variations, even post-certification.